Trial Outcomes & Findings for The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS) (NCT NCT02691455)
NCT ID: NCT02691455
Last Updated: 2021-11-02
Results Overview
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).
TERMINATED
NA
50 participants
from time of intervention to month 6
2021-11-02
Participant Flow
5 enrolled participants did not meet eligibility criteria and were excluded. Only one eye of each participant was eligible for enrollment.
Unit of analysis: eyes
Participant milestones
| Measure |
Second Aqueous Shunt
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Overall Study
STARTED
|
23 23
|
22 22
|
|
Overall Study
Randomized
|
23 23
|
22 22
|
|
Overall Study
Received Assigned Intervention
|
22 22
|
20 20
|
|
Overall Study
Week 1 Follow up
|
22 22
|
19 19
|
|
Overall Study
Month 1 Follow up
|
22 22
|
18 18
|
|
Overall Study
Month 3 Follow up
|
21 21
|
18 18
|
|
Overall Study
Month 6 Follow up
|
19 19
|
19 19
|
|
Overall Study
Month 12 Follow up
|
16 16
|
16 16
|
|
Overall Study
Year 2 Follow up
|
6 6
|
9 9
|
|
Overall Study
Year 3 Follow up
|
7 7
|
5 5
|
|
Overall Study
COMPLETED
|
7 7
|
5 5
|
|
Overall Study
NOT COMPLETED
|
16 16
|
17 17
|
Reasons for withdrawal
| Measure |
Second Aqueous Shunt
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
15
|
15
|
Baseline Characteristics
The American Glaucoma Society (AGS) Second Aqueous Shunt Implant vs. Transscleral Cyclophotocoagulation Treatment Study (ASSISTS)
Baseline characteristics by cohort
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=20 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Number of participants with hypertension
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Number of participants with diabetes
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Number of participants with autoimmune disease
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Number of participants for whom study eye is right eye
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Glaucoma type
Primary Open Angle
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Glaucoma type
Primary Angle Closure
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Glaucoma type
Mixed Open and Closed Glaucoma
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Glaucoma type
Neovascular
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Glaucoma type
Uveitis
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Glaucoma type
Other Secondary Glaucoma
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Intraocular pressure (IOP)
|
27.6 mmHg
STANDARD_DEVIATION 8.7 • n=5 Participants
|
26.2 mmHg
STANDARD_DEVIATION 9.7 • n=7 Participants
|
26.9 mmHg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Number of participants on ocular hypertensive medications
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Number of ocular hypertensive medications per participant
|
3.2 medications
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.3 medications
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.2 medications
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Number of participants on oral carbonic anhydrase inhibitor (CAI)
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Best corrected visual acuity as Assessed by the Snellen Chart Visual Acuity Test
|
0.97 logMAR
STANDARD_DEVIATION 0.90 • n=5 Participants
|
0.49 logMAR
STANDARD_DEVIATION 0.66 • n=7 Participants
|
0.74 logMAR
STANDARD_DEVIATION 0.82 • n=5 Participants
|
PRIMARY outcome
Timeframe: from time of intervention to month 6Population: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Number of Eyes That Failed Treatment
|
0 eyes
|
0 eyes
|
PRIMARY outcome
Timeframe: from month 6 to month 12Population: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 4 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).
Outcome measures
| Measure |
Second Aqueous Shunt
n=18 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Number of Eyes That Failed Treatment
|
3 eyes
|
2 eyes
|
PRIMARY outcome
Timeframe: from month 12 to year 3Population: Only one eye of each participant was eligible for enrollment. Only those who did not fail treatment in the previous time period (previous time period is reported in Outcome measure 2) were analyzed in this time period. Data for this outcome measure were not collected for 15 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Treatment failure is defined as meeting one or more of the following 4 criteria: 1. Intraocular pressure (IOP) a) \>18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of \< 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or 2. Reoperation for glaucoma; or 3. Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or 4. Loss of light perception vision (NLP).
Outcome measures
| Measure |
Second Aqueous Shunt
n=7 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Number of Eyes That Failed Treatment
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: from the time of intervention to year 3Population: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Number of Eyes With Vision-threatening Complications
Second Tube Migration Anteriorly
|
1 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Hyphema
|
2 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Hypotony persistent
|
2 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Choroidal Effusion
|
1 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Cystoid/Diabetic Macular Edema Progression
|
2 eyes
|
3 eyes
|
|
Number of Eyes With Vision-threatening Complications
Primary Tube Complications
|
2 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Cataract Progression
|
0 eyes
|
3 eyes
|
|
Number of Eyes With Vision-threatening Complications
Macular Hole
|
0 eyes
|
1 eyes
|
|
Number of Eyes With Vision-threatening Complications
Herpes Simplex Keratitis
|
1 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Ectropion
|
1 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Vitreous Clogging Second glaucoma drainage device
|
1 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Intraocular Lens Dislocation
|
1 eyes
|
0 eyes
|
|
Number of Eyes With Vision-threatening Complications
Phacodonesis
|
0 eyes
|
1 eyes
|
SECONDARY outcome
Timeframe: from time of intervention to year 3Population: Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The Snellen visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). Loss of lines of vision indicates worsening visual acuity.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test
|
3 eyes
|
8 eyes
|
SECONDARY outcome
Timeframe: baseline, week 1Population: Data for this outcome measure was not collected 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The week 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
|
0.16 log MAgnification Requirement (logMAR)
Standard Deviation 0.45
|
0.14 log MAgnification Requirement (logMAR)
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: baseline, month 1Population: Data for this outcome measure was not collected for 5 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=15 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
|
-0.03 log MAgnification Requirement (logMAR)
Standard Deviation 0.18
|
0.12 log MAgnification Requirement (logMAR)
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: baseline, month 3Population: Data for this outcome measure were not collected for 1 in the Second Aqueous Shunt arm and 3 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Outcome measures
| Measure |
Second Aqueous Shunt
n=21 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=17 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
|
-0.10 log MAgnification Requirement (logMAR)
Standard Deviation 0.27
|
0.08 log MAgnification Requirement (logMAR)
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: baseline, month 6Population: Data for this outcome measure were not collected for 3 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 6 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Outcome measures
| Measure |
Second Aqueous Shunt
n=19 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
|
-0.03 log MAgnification Requirement (logMAR)
Standard Deviation 0.28
|
0.05 log MAgnification Requirement (logMAR)
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: baseline, month 12Population: Data for this outcome measure were not collected for 6 in the Second Aqueous Shunt arm and 4 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 12 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Outcome measures
| Measure |
Second Aqueous Shunt
n=16 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=16 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
|
-0.06 log MAgnification Requirement (logMAR)
Standard Deviation 0.34
|
0.09 log MAgnification Requirement (logMAR)
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: baseline, year 2Population: Data for this outcome measure were not collected for 16 in the Second Aqueous Shunt arm and 11 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 2 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Outcome measures
| Measure |
Second Aqueous Shunt
n=6 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=9 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
|
-0.28 log MAgnification Requirement (logMAR)
Standard Deviation 0.28
|
0.24 log MAgnification Requirement (logMAR)
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: baseline, year 3Population: Data for this outcome measure were not collected for 16 in the Second Aqueous Shunt arm and 15 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).
Outcome measures
| Measure |
Second Aqueous Shunt
n=6 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=5 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test
|
-0.23 log MAgnification Requirement (logMAR)
Standard Deviation 0.36
|
0.49 log MAgnification Requirement (logMAR)
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Data for this outcome measure were not collected for 1 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Number of participants who reported pain.
Outcome measures
| Measure |
Second Aqueous Shunt
n=21 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=18 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Incidence of Pain
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Number of participants who reported pain.
Outcome measures
| Measure |
Second Aqueous Shunt
n=20 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=18 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Incidence of Pain
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.
Outcome measures
| Measure |
Second Aqueous Shunt
n=21 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=18 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Severity of Pain
|
1.57 score on a scale
Standard Deviation 1.99
|
1.44 score on a scale
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.
Outcome measures
| Measure |
Second Aqueous Shunt
n=20 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=18 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Severity of Pain
|
1.40 score on a scale
Standard Deviation 2.23
|
1.28 score on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: from baseline to 3 monthsPopulation: Data for this outcome measure were not collected 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Number of Office Visits Per Participant From Baseline to 3 Months
|
3.73 office visits per participant
Standard Deviation 2.53
|
0.95 office visits per participant
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: from month 4 to year 3Population: Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
Outcome measures
| Measure |
Second Aqueous Shunt
n=20 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Number of Office Visits Per Participant Per Month After Month 3
|
0.35 office visits per participant per month
Standard Deviation 0.34
|
0.13 office visits per participant per month
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute (NEI) Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale
|
62.5 score on a scale
Standard Deviation 21.5
|
48.7 score on a scale
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale
|
58.9 score on a scale
Standard Deviation 23.2
|
53.8 score on a scale
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
|
64.5 score on a scale
Standard Deviation 23.0
|
63.2 score on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale
|
64.3 score on a scale
Standard Deviation 21.0
|
70.8 score on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
|
55.4 score on a scale
Standard Deviation 28.8
|
56.9 score on a scale
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale
|
57.6 score on a scale
Standard Deviation 28.1
|
68.3 score on a scale
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
|
65.8 score on a scale
Standard Deviation 24.2
|
63.5 score on a scale
Standard Deviation 25.4
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale
|
75.8 score on a scale
Standard Deviation 20.2
|
63.9 score on a scale
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
|
66.3 score on a scale
Standard Deviation 21.0
|
62.7 score on a scale
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale
|
71.2 score on a scale
Standard Deviation 22.7
|
59.0 score on a scale
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
|
60.2 score on a scale
Standard Deviation 24.0
|
59.2 score on a scale
Standard Deviation 33.6
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale
|
62.5 score on a scale
Standard Deviation 23.5
|
63.5 score on a scale
Standard Deviation 33.3
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
|
86.4 score on a scale
Standard Deviation 22.8
|
77.6 score on a scale
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale
|
91.1 score on a scale
Standard Deviation 23.2
|
76.9 score on a scale
Standard Deviation 25.9
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
|
76.2 score on a scale
Standard Deviation 28.6
|
70.4 score on a scale
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale
|
83.0 score on a scale
Standard Deviation 20.0
|
81.7 score on a scale
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
|
63.1 score on a scale
Standard Deviation 25.0
|
55.4 score on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale
|
56.5 score on a scale
Standard Deviation 17.6
|
65.8 score on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
|
50.2 score on a scale
Standard Deviation 22.5
|
46.7 score on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale
|
49.3 score on a scale
Standard Deviation 24.4
|
54.9 score on a scale
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
|
83.1 score on a scale
Standard Deviation 18.7
|
82.7 score on a scale
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale
|
83.3 score on a scale
Standard Deviation 26.3
|
76.0 score on a scale
Standard Deviation 34.8
|
SECONDARY outcome
Timeframe: baselinePopulation: Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=22 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=19 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
|
54.8 score on a scale
Standard Deviation 31.2
|
61.8 score on a scale
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: month 12Population: Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.
The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Outcome measures
| Measure |
Second Aqueous Shunt
n=14 Participants
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=13 Participants
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale
|
63.4 score on a scale
Standard Deviation 25.7
|
70.2 score on a scale
Standard Deviation 31.7
|
Adverse Events
Second Aqueous Shunt
Transscleral Cyclophotocoagulation
Serious adverse events
| Measure |
Second Aqueous Shunt
n=22 participants at risk
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=20 participants at risk
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
General disorders
Death
|
13.6%
3/22 • Number of events 3 • 3 years
|
0.00%
0/20 • 3 years
|
|
Infections and infestations
Central Nervous System (CNS) Syphilis causing Pan Uveitis
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Lung Malignancy
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Hyphema
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Vascular disorders
Chest pain secondary to abdominal artery pseudoaneurysm
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Infections and infestations
Pneumonia
|
9.1%
2/22 • Number of events 2 • 3 years
|
0.00%
0/20 • 3 years
|
|
Vascular disorders
Acute on Chronic Combined Diastolic and Systolic Congestive Heart Failure exacerbation
|
4.5%
1/22 • Number of events 2 • 3 years
|
0.00%
0/20 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left atrial myxoma
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Vascular disorders
Pericardial effusion
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Infections and infestations
Purulent Constrictive Pericarditis, unspecified infectious etiology
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Vascular disorders
Heart Attack
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Vascular disorders
Non-ST-Elevation Myocardial Infarction
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Eye disorders
Open Globe due to trauma
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Second Aqueous Shunt
n=22 participants at risk
Second Aqueous Shunt
Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.
Baerveldt Glaucoma Implant 350-mm2 / BG101-350
Ahmed Model FP7 Flexible Plate
Baerveldt Glaucoma Implant 250-mm2 / BG103-250
|
Transscleral Cyclophotocoagulation
n=20 participants at risk
Transscleral Diode Laser Cyclophotocoagulation
Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute on Chronic Respiratory Failure with Hypoxemia and Hypercapnia
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Castochondritis
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Choroidals
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Corneal Epithelial Defect
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Decreased Visual Acuity
|
9.1%
2/22 • Number of events 2 • 3 years
|
20.0%
4/20 • Number of events 4 • 3 years
|
|
Eye disorders
Development of Cystoid Macular Edema
|
4.5%
1/22 • Number of events 1 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Eye disorders
Worsening of Cystoid Macular Edema
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dislipidemia
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Diabetic Macular Edema
|
4.5%
1/22 • Number of events 1 • 3 years
|
5.0%
1/20 • Number of events 2 • 3 years
|
|
Eye disorders
Ectropion
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Worsening Diabetic Retinopathy
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Eye disorders
Filamentary Keratitis
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Herpes Simplex Virus Dendritic Keratitis
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Hyphema
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Hypotony of eye
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Infections and infestations
Leak/Inflammation or infection of eye
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Mild intraocular lens dislocation (inferior nasal)
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Overfiltration of Eye
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Vascular disorders
Pulmonary Hypertension (secondary)
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Re-exposed tube
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Ssuperior nasal tube with <1 mm exposure at limbus (original tube)
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
General disorders
Spot on gums
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Malignancy
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Trabectome/Goniotomy of eye
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Tube Migration Anteriorly
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Vision loss from count fingers to light perception
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Vitreous clogging of second tube shunt
|
4.5%
1/22 • Number of events 1 • 3 years
|
0.00%
0/20 • 3 years
|
|
Eye disorders
Cataract formation
|
0.00%
0/22 • 3 years
|
15.0%
3/20 • Number of events 3 • 3 years
|
|
Eye disorders
Worsening of cataract
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Eye disorders
Macular hole
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Eye disorders
No light perception
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
|
Eye disorders
Phacodonesis
|
0.00%
0/22 • 3 years
|
5.0%
1/20 • Number of events 1 • 3 years
|
Additional Information
Robert M. Feldman, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place