Trial Outcomes & Findings for The Baerveldt Versus ClearPath Comparison Study (NCT NCT04468633)
NCT ID: NCT04468633
Last Updated: 2024-09-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Results posted on
2024-09-05
Participant Flow
Participants were recruited from the Duke Eye Center (Durham, NC, USA) and its satellite locations from December 2020 to June 2023.
Unit of analysis: eyes
Participant milestones
| Measure |
Baerveldt 350 Implant
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Overall Study
STARTED
|
37 37
|
39 39
|
|
Overall Study
COMPLETED
|
33 33
|
39 39
|
|
Overall Study
NOT COMPLETED
|
4 4
|
0 0
|
Reasons for withdrawal
| Measure |
Baerveldt 350 Implant
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
The Baerveldt Versus ClearPath Comparison Study
Baseline characteristics by cohort
| Measure |
Baerveldt 350 Implant
n=37 Participants
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=39 Participants
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
70.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1Population: Participants with data collected at each timepoint.
Outcome measures
| Measure |
Baerveldt 350 Implant
n=33 eyes
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=39 eyes
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Intraocular Pressure (IOP)
Baseline
|
21.7 mmHg
Standard Deviation 7.1
|
22.4 mmHg
Standard Deviation 6.7
|
|
Intraocular Pressure (IOP)
Day 1
|
14.9 mmHg
Standard Deviation 12.1
|
12.6 mmHg
Standard Deviation 10.5
|
|
Intraocular Pressure (IOP)
Week 1
|
10.7 mmHg
Standard Deviation 5.8
|
11.5 mmHg
Standard Deviation 6.5
|
|
Intraocular Pressure (IOP)
Week 4
|
16.0 mmHg
Standard Deviation 8.1
|
15.6 mmHg
Standard Deviation 9.2
|
|
Intraocular Pressure (IOP)
Week 6
|
16.2 mmHg
Standard Deviation 9.7
|
12.1 mmHg
Standard Deviation 5.4
|
|
Intraocular Pressure (IOP)
Month 3
|
16.5 mmHg
Standard Deviation 6.6
|
12.8 mmHg
Standard Deviation 6.5
|
|
Intraocular Pressure (IOP)
Month 6
|
14.0 mmHg
Standard Deviation 4.3
|
12.5 mmHg
Standard Deviation 4.5
|
|
Intraocular Pressure (IOP)
Month 12
|
14.1 mmHg
Standard Deviation 4.3
|
11.4 mmHg
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Up to Year 1Outcome measures
| Measure |
Baerveldt 350 Implant
n=37 Participants
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=39 Participants
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Number of Participants Who Experienced a Complication
|
13 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1Population: Participants with data collected at each timepoint.
Outcome measures
| Measure |
Baerveldt 350 Implant
n=33 eyes
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=39 eyes
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Best Corrected Visual Acuity (BCVA)
Baseline
|
0.40 LogMAR
Standard Deviation 0.53
|
0.56 LogMAR
Standard Deviation 0.71
|
|
Best Corrected Visual Acuity (BCVA)
Day 1
|
0.71 LogMAR
Standard Deviation 0.66
|
1.09 LogMAR
Standard Deviation 0.86
|
|
Best Corrected Visual Acuity (BCVA)
Week 1
|
0.65 LogMAR
Standard Deviation 0.68
|
1.03 LogMAR
Standard Deviation 0.87
|
|
Best Corrected Visual Acuity (BCVA)
Week 4
|
0.45 LogMAR
Standard Deviation 0.50
|
0.71 LogMAR
Standard Deviation 0.84
|
|
Best Corrected Visual Acuity (BCVA)
Week 6
|
0.49 LogMAR
Standard Deviation 0.68
|
0.71 LogMAR
Standard Deviation 0.86
|
|
Best Corrected Visual Acuity (BCVA)
Month 3
|
0.44 LogMAR
Standard Deviation 0.68
|
0.77 LogMAR
Standard Deviation 0.88
|
|
Best Corrected Visual Acuity (BCVA)
Month 6
|
0.46 LogMAR
Standard Deviation 0.68
|
0.71 LogMAR
Standard Deviation 0.80
|
|
Best Corrected Visual Acuity (BCVA)
Year 1
|
0.36 LogMAR
Standard Deviation 0.55
|
0.72 LogMAR
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1Population: Participants with data collected at each timepoint.
Outcome measures
| Measure |
Baerveldt 350 Implant
n=33 Participants
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=39 Participants
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Baseline
|
2.7 medications
Standard Deviation 1.1
|
2.7 medications
Standard Deviation 1.5
|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Day 1
|
0.6 medications
Standard Deviation 0.8
|
0.7 medications
Standard Deviation 1.2
|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Week 1
|
0.8 medications
Standard Deviation 1.2
|
0.9 medications
Standard Deviation 1.4
|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Week 4
|
1.1 medications
Standard Deviation 1.3
|
1.2 medications
Standard Deviation 1.5
|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Week 6
|
1.4 medications
Standard Deviation 1.3
|
1.1 medications
Standard Deviation 1.3
|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Month 3
|
1.5 medications
Standard Deviation 1.2
|
1.4 medications
Standard Deviation 1.3
|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Month 6
|
2.0 medications
Standard Deviation 1.3
|
1.7 medications
Standard Deviation 1.4
|
|
Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
Month 12
|
2.3 medications
Standard Deviation 1.2
|
1.6 medications
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and Year 1Population: Participants with data collected at both timepoints.
The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.
Outcome measures
| Measure |
Baerveldt 350 Implant
n=27 Participants
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=25 Participants
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Change in Humphrey Visual Field (HVF)
|
2.81 dB
Standard Deviation 9.58
|
4.72 dB
Standard Deviation 13.55
|
SECONDARY outcome
Timeframe: Baseline and Year 1Population: Participants with data collected at both timepoints.
Pachymetry is an ophthalmological test that measures the thickness of the cornea.
Outcome measures
| Measure |
Baerveldt 350 Implant
n=28 Participants
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=26 Participants
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Change in Thickness of the Cornea as Measured by Pachymetry
|
12.18 µm
Standard Deviation 25.86
|
25.96 µm
Standard Deviation 57.79
|
SECONDARY outcome
Timeframe: Baseline and Year 1Population: Participants with data collected at both timepoints.
The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.
Outcome measures
| Measure |
Baerveldt 350 Implant
n=27 Participants
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=25 Participants
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Change in Retinal Nerve Fiber Layer (RNFL)
|
2.81 µm
Standard Deviation 9.58
|
4.72 µm
Standard Deviation 13.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Year 1Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Year 1Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Year 1If patient is binocular
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Year 1If patient is binocular
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Year 1If patient is binocular
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Year 1Outcome measures
Outcome data not reported
Adverse Events
Baerveldt 350 Implant
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Ahmed ClearPath 350 Implant
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Baerveldt 350 Implant
n=37 participants at risk
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=39 participants at risk
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction (heart attack)
|
2.7%
1/37 • Up to 1 year
|
0.00%
0/39 • Up to 1 year
|
Other adverse events
| Measure |
Baerveldt 350 Implant
n=37 participants at risk
Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.
|
Ahmed ClearPath 350 Implant
n=39 participants at risk
Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.
|
|---|---|---|
|
Surgical and medical procedures
Surgical failure
|
24.3%
9/37 • Up to 1 year
|
20.5%
8/39 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place