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=5 Participants	67.0 years STANDARD_DEVIATION 10.1 • n=7 Participants	67.3 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Mixed Race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Brazil	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Pre-operative intraocular pressure	29.91 mmHg STANDARD_DEVIATION 6.55 • n=5 Participants	33.79 mmHg STANDARD_DEVIATION 10.54 • n=7 Participants	31.85 mmHg STANDARD_DEVIATION 8.55 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

The 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 months

The 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 months

Surgical 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

Peter A. Netland, MD, PhD

University of Virginia

Phone: 4349821086

Email: pan9c@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place