Trial Outcomes & Findings for Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma (NCT NCT00869141)

NCT ID: NCT00869141

Last Updated: 2015-12-30

Results Overview

Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: within 6 months after surgery
• Results posted on: 2015-12-30

Participant Flow

Participant milestones

Measure	Research Arm Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation	Standard of Care Arm Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation
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

Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

Baseline characteristics by cohort

Measure	Research Arm n=26 Participants Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation	Standard of Care Arm n=26 Participants Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation	Total n=52 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 11.6 • n=5 Participants	61.6 years STANDARD_DEVIATION 15.3 • n=7 Participants	64.3 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	21 Participants n=7 Participants	44 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 6 months after surgery

Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week

Outcome measures

Measure	Research Arm n=26 Participants Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation	Standard of Care Arm n=26 Participants Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma	9 participants	12 participants

PRIMARY outcome

Timeframe: 3 weeks after surgery

Population: Eye pressure at postop 3-week is reported

intraocular pressure comparison between groups after the Ahmed valve implantation

Outcome measures

Measure	Research Arm n=26 Participants Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation	Standard of Care Arm n=26 Participants Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation
Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma	15.6 mmHg at postop 3-week Standard Deviation 3.6	20.6 mmHg at postop 3-week Standard Deviation 8.9

PRIMARY outcome

Timeframe: 1 year after surgery

Population: Please note that these two groups were different from those groups in previous comparison. The patients that developed hypertensive phase were compared to those that did not developed hypertensive phase, so the number of patients in these two groups and the mean pressure at 1 year +/-standard deviation results were different.

intraocular pressure of eyes with hypertensive phase versus without hypertensive phase

Outcome measures

Measure	Research Arm n=21 Participants Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation	Standard of Care Arm n=31 Participants Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation
Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase	15.1 mmHg in 1 year postop Standard Deviation 5.2	11.4 mmHg in 1 year postop Standard Deviation 4.3

Adverse Events

Research Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Research Arm n=26 participants at risk Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation	Standard of Care Arm n=26 participants at risk Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation
Eye disorders Uveitis and conreal edema	0.00% 0/26	7.7% 2/26 • Number of events 2
Eye disorders Strabismus	3.8% 1/26 • Number of events 1	0.00% 0/26

Additional Information

Dr. Simon K. Law

Stein Eye Institute

Phone: (310)794-1477

Email: law@jsei.ucla.edu

Results disclosure agreements

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