Trial Outcomes & Findings for Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves (NCT NCT01883856)
NCT ID: NCT01883856
Last Updated: 2020-10-19
Results Overview
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
12 months
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
Silicone Plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.
|
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Baseline characteristics by cohort
| Measure |
Silicone Plate Ahmed Glaucoma Valve
n=26 Participants
Silicone plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.
|
Porous Plate Ahmed Glaucoma Valve
n=26 Participants
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
67.0 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
67.3 years
STANDARD_DEVIATION 10.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · African American
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed Race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Pre-operative intraocular pressure
|
29.91 mmHg
STANDARD_DEVIATION 6.55 • n=99 Participants
|
33.79 mmHg
STANDARD_DEVIATION 10.54 • n=107 Participants
|
31.85 mmHg
STANDARD_DEVIATION 8.55 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
Outcome measures
| Measure |
Silicone Plate Ahmed Glaucoma Valve
n=26 Participants
Silicone plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.
|
Porous Plate Ahmed Glaucoma Valve
n=26 Participants
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.
|
|---|---|---|
|
Change in Intraocular Pressure
|
13.60 mmHg
Standard Deviation 4.69
|
17.94 mmHg
Standard Deviation 10.95
|
SECONDARY outcome
Timeframe: 12 monthsThe mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.
Outcome measures
| Measure |
Silicone Plate Ahmed Glaucoma Valve
n=26 Participants
Silicone plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.
|
Porous Plate Ahmed Glaucoma Valve
n=26 Participants
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.
|
|---|---|---|
|
Anti-Glaucoma Medications
|
1.64 glaucoma medications
Standard Deviation 1.40
|
1.89 glaucoma medications
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: 12 monthsSurgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures.
Outcome measures
| Measure |
Silicone Plate Ahmed Glaucoma Valve
n=26 Participants
Silicone plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.
|
Porous Plate Ahmed Glaucoma Valve
n=26 Participants
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.
|
|---|---|---|
|
Surgical Success
|
23 surgical success
|
14 surgical success
|
Adverse Events
Silicone Plate Ahmed Glaucoma Valve
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Porous Plate Ahmed Glaucoma Valve
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Silicone Plate Ahmed Glaucoma Valve
n=26 participants at risk
Silicone plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.
|
Porous Plate Ahmed Glaucoma Valve
n=26 participants at risk
Porous Plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.
|
|---|---|---|
|
Eye disorders
Hypertensive phase
|
50.0%
13/26 • Number of events 13 • 1 year
|
57.7%
15/26 • Number of events 15 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place