Phase 4
N=52
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00869141 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma — 9; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma |
9; 12 | — |
| PRIMARY Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma |
15.6; 20.6 | — |
| PRIMARY Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase |
15.1; 11.4 | — |
Summary
The purpose of this study is to compare the occurrence rate of the high pressure phase and the final pressure outcomes between patients treated with glaucoma medication prior to the expected onset of the high pressure phase to those patients who have glaucoma medication started at the onset of the high pressure phase. The investigators hypothesize that if glaucoma medications are started prior to the expected onset of high pressure phase, the high pressure phase will not occur as frequently and the ultimate pressure level will be lower than if the glaucoma medications are started at the onset of this phase.
Eligibility Criteria
Inclusion Criteria
- Patients requiring Ahmed glaucoma valve implantation to control intraocular pressure between the ages of 18 and 85 years.
Exclusion Criteria
- Unwilling or unable to give consent or unwilling to accept randomization.
- Patient out of area and potentially unavailable for follow-up visits.
- Known allergic reaction to timolol, brimonidine, dorzolamide, brinzolamide, or sulfa drugs.
- Known medical contraindications to the use of beta-blockers, including congestive heart failure, heart block, asthma, and chronic obstructive pulmonary disease.
- Concurrent intraocular procedure with Ahmed glaucoma valve implantation
- Previous Ahmed glaucoma valve implantation
Data sourced from ClinicalTrials.gov (NCT00869141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.