N/A
N=52
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01883856 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change in Intraocular Pressure — 13.60; 17.94 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Silicone plate Ahmed Glaucoma Valve (Model FP7) (Device); Porous Plate Ahmed Glaucoma Valve (Model M4) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peter Netland, MD
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure |
13.60; 17.94 | — |
| SECONDARY Anti-Glaucoma Medications |
1.64; 1.89 | — |
| SECONDARY Surgical Success |
23; 14 | — |
Summary
The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.
Eligibility Criteria
Inclusion Criteria
- Male or female of any race ≥ 18 years and ≤ 80 years of age.
- Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
- Elevated intraocular pressure > 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
- Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
- Subject is willing and able to sign the informed consent.
Exclusion Criteria
- Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
- History of prior drainage implant surgery in the study eye.
- History of cyclophotocoagulation of the study eye.
- Pregnancy.
- Prisoner.
Data sourced from ClinicalTrials.gov (NCT01883856). 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.