Trial Outcomes & Findings for Primary Tube Versus Trabeculectomy Study (NCT NCT00666237)
NCT ID: NCT00666237
Last Updated: 2022-10-19
Results Overview
Surgical failure is defined as: 1. Inadequate Intraocular Pressure (IOP) Reduction (IOP \> 21 mmHg or reduced \< 20% below baseline on 2 consecutive follow-up visits after 3 months) 2. Reoperation for glaucoma 3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) 4. Loss of light perception vision
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
242 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2022-10-19
Participant Flow
Participant milestones
| Measure |
Tube Shunt Surgery Group
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
117
|
|
Overall Study
COMPLETED
|
91
|
87
|
|
Overall Study
NOT COMPLETED
|
34
|
30
|
Reasons for withdrawal
| Measure |
Tube Shunt Surgery Group
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Overall Study
Death
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
29
|
25
|
Baseline Characteristics
Primary Tube Versus Trabeculectomy Study
Baseline characteristics by cohort
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: The number of participants requiring glaucoma operations includes only those that had a failed surgery due to glaucoma reoperation.
Surgical failure is defined as: 1. Inadequate Intraocular Pressure (IOP) Reduction (IOP \> 21 mmHg or reduced \< 20% below baseline on 2 consecutive follow-up visits after 3 months) 2. Reoperation for glaucoma 3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) 4. Loss of light perception vision
Outcome measures
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Number of Participants With Surgical Failure
Inadequate IOP reduction
|
31 Participants
|
23 Participants
|
|
Number of Participants With Surgical Failure
Reoperation for Glaucoma
|
18 Participants
|
9 Participants
|
|
Number of Participants With Surgical Failure
Loss of light perception vision
|
0 Participants
|
1 Participants
|
|
Number of Participants With Surgical Failure
Persistent Hypotony
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 yearsPopulation: Participants who underwent additional glaucoma surgery were censored from analysis after reoperation. Not all participants completed all visits to complete the IOP assessment.
Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.
Outcome measures
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Intraocular Pressure
Intraocular Pressure: Baseline
|
23.3 mmHg
Standard Deviation 4.9
|
23.9 mmHg
Standard Deviation 5.7
|
|
Intraocular Pressure
Intraocular Pressure: 1 year
|
13.8 mmHg
Standard Deviation 4.1
|
12.4 mmHg
Standard Deviation 4.4
|
|
Intraocular Pressure
Intraocular Pressure: 18 months
|
13.5 mmHg
Standard Deviation 4.1
|
12.8 mmHg
Standard Deviation 4.7
|
|
Intraocular Pressure
Intraocular Pressure: 2 years
|
13.6 mmHg
Standard Deviation 3.9
|
12.9 mmHg
Standard Deviation 5.2
|
|
Intraocular Pressure
Intraocular Pressure: 3 years
|
13.9 mmHg
Standard Deviation 4.2
|
12.1 mmHg
Standard Deviation 4.8
|
|
Intraocular Pressure
Intraocular Pressure: 4 years
|
13.5 mmHg
Standard Deviation 3.5
|
13.5 mmHg
Standard Deviation 5.4
|
|
Intraocular Pressure
Intraocular Pressure: 5 years
|
13.4 mmHg
Standard Deviation 3.5
|
13.0 mmHg
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of participants with early and late postoperative complications will be reported as per treating physician assessment
Outcome measures
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Number of Participants With Reported Postoperative Complications
Early Postoperative Complications
|
24 Participants
|
40 Participants
|
|
Number of Participants With Reported Postoperative Complications
Late Postoperative Complications
|
27 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: At Baseline, At 5 yearsPopulation: Not all participants were able to complete the 5 year follow up visit and assessments.
Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Outcome measures
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Visual Acuity Using a Snellen Chart
Baseline
|
0.20 logMAR
Standard Deviation 0.42
|
0.25 logMAR
Standard Deviation 0.51
|
|
Visual Acuity Using a Snellen Chart
5 years
|
0.30 logMAR
Standard Deviation 0.54
|
0.42 logMAR
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: At baseline, At 5 yearsPopulation: Not all participants were able to complete the 5 year follow up visit and assessments.
Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity.
Outcome measures
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Visual Acuity as Measured Using EDTRS Chart
Baseline
|
73 letters
Standard Deviation 20
|
73 letters
Standard Deviation 20
|
|
Visual Acuity as Measured Using EDTRS Chart
5 years
|
69 letters
Standard Deviation 23
|
66 letters
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: No data is reported for this outcome as data can not be extracted from system despite exhausting all efforts to do so.
Visual fields will be measured using standard automated perimetry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The number of participants requiring glaucoma operations includes those that had a failed surgery due to glaucoma reoperation, as well as, other patients who failed because of inadequate intraocular pressure reduction and subsequently underwent glaucoma surgery.
The number of participants requiring reoperation for glaucoma will be reported
Outcome measures
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Reoperation for Glaucoma
|
21 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 yearsPopulation: Participants who underwent additional glaucoma surgery were censored from analysis after reoperation. Not all participants completed all visits to complete assessment.
The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used
Outcome measures
| Measure |
Tube Shunt Surgery Group
n=125 Participants
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 Participants
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Number of Glaucoma Medications
18 months
|
2.1 glaucoma medications used
Standard Deviation 1.3
|
0.8 glaucoma medications used
Standard Deviation 1.3
|
|
Number of Glaucoma Medications
Baseline
|
3.1 glaucoma medications used
Standard Deviation 1.1
|
3.2 glaucoma medications used
Standard Deviation 1.1
|
|
Number of Glaucoma Medications
1 year
|
2.1 glaucoma medications used
Standard Deviation 1.4
|
0.9 glaucoma medications used
Standard Deviation 1.4
|
|
Number of Glaucoma Medications
2 years
|
2.2 glaucoma medications used
Standard Deviation 1.0
|
1.0 glaucoma medications used
Standard Deviation 1.5
|
|
Number of Glaucoma Medications
3 years
|
2.1 glaucoma medications used
Standard Deviation 1.4
|
1.2 glaucoma medications used
Standard Deviation 1.5
|
|
Number of Glaucoma Medications
4 years
|
2.3 glaucoma medications used
Standard Deviation 1.4
|
1.3 glaucoma medications used
Standard Deviation 1.4
|
|
Number of Glaucoma Medications
5 years
|
2.2 glaucoma medications used
Standard Deviation 1.3
|
1.3 glaucoma medications used
Standard Deviation 1.4
|
Adverse Events
Tube Shunt Surgery Group
Serious events: 0 serious events
Other events: 51 other events
Deaths: 5 deaths
Trabeculectomy With Mitomycin C
Serious events: 0 serious events
Other events: 72 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tube Shunt Surgery Group
n=125 participants at risk
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Tube shunt surgery: The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
|
Trabeculectomy With Mitomycin C
n=117 participants at risk
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Trabeculectomy: The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
Mitomycin C: A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
|
|---|---|---|
|
Eye disorders
Dysethesia
|
0.80%
1/125 • Number of events 1 • 5 years
|
2.6%
3/117 • Number of events 3 • 5 years
|
|
Eye disorders
Persistent Corneal Edema
|
0.00%
0/125 • 5 years
|
2.6%
3/117 • Number of events 3 • 5 years
|
|
Eye disorders
Shallow or flat anterior chamber
|
12.0%
15/125 • Number of events 15 • 5 years
|
12.8%
15/117 • Number of events 15 • 5 years
|
|
Eye disorders
Choroidal Effusion
|
8.8%
11/125 • Number of events 11 • 5 years
|
10.3%
12/117 • Number of events 12 • 5 years
|
|
Surgical and medical procedures
Wound Leak
|
0.80%
1/125 • Number of events 1 • 5 years
|
11.1%
13/117 • Number of events 13 • 5 years
|
|
Eye disorders
Hyphema
|
6.4%
8/125 • Number of events 8 • 5 years
|
4.3%
5/117 • Number of events 5 • 5 years
|
|
Eye disorders
Encapsulated bleb
|
10.4%
13/125 • Number of events 13 • 5 years
|
22.2%
26/117 • Number of events 26 • 5 years
|
|
Eye disorders
Hypotony Maculopathy
|
0.80%
1/125 • Number of events 1 • 5 years
|
5.1%
6/117 • Number of events 6 • 5 years
|
|
Surgical and medical procedures
Wound Dehiscence
|
1.6%
2/125 • Number of events 2 • 5 years
|
0.00%
0/117 • 5 years
|
|
Eye disorders
Aqueous Misdirection
|
0.00%
0/125 • 5 years
|
0.85%
1/117 • Number of events 1 • 5 years
|
|
Eye disorders
Corneal Dellen
|
0.80%
1/125 • Number of events 1 • 5 years
|
0.00%
0/117 • 5 years
|
|
Eye disorders
Cystoid Macular Edema
|
2.4%
3/125 • Number of events 3 • 5 years
|
0.00%
0/117 • 5 years
|
|
Infections and infestations
Suture-related infection
|
0.00%
0/125 • 5 years
|
0.85%
1/117 • Number of events 1 • 5 years
|
|
Eye disorders
Persistent Diploplia
|
4.0%
5/125 • Number of events 5 • 5 years
|
2.6%
3/117 • Number of events 3 • 5 years
|
|
Eye disorders
Iritis
|
1.6%
2/125 • Number of events 2 • 5 years
|
0.85%
1/117 • Number of events 1 • 5 years
|
|
Eye disorders
Bleb Leak
|
0.00%
0/125 • 5 years
|
0.85%
1/117 • Number of events 1 • 5 years
|
|
Eye disorders
Conjunctival Cyst
|
0.80%
1/125 • Number of events 1 • 5 years
|
0.00%
0/117 • 5 years
|
|
Eye disorders
Anterior Bleb Migration with Irregular Astigmatism
|
0.00%
0/125 • 5 years
|
0.85%
1/117 • Number of events 1 • 5 years
|
|
Eye disorders
Plate erosion
|
0.80%
1/125 • Number of events 1 • 5 years
|
0.00%
0/117 • 5 years
|
|
Eye disorders
Tube retraction
|
0.80%
1/125 • Number of events 1 • 5 years
|
0.00%
0/117 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place