Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma
Phase 3
Completed
- Conditions
- Refractory Glaucoma
- Interventions
- Device: Molteno single-plate implant (MSPI)Device: Ahmed valve implant
- Registration Number
- NCT00971061
- Lead Sponsor
- Vanak Eye Surgery Center
- Brief Summary
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.
Exclusion Criteria
- age less than 40 years
- a visual acuity of no light perception
- lens opacity
- elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
- previous cyclodestructive treatment
- increased risk of endophthalmitis posterior segment disorders
- pre-existing ocular comorbidities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MSPI Molteno single-plate implant (MSPI) Molteno single-plate implant AVI Ahmed valve implant Ahmed valve implant
- Primary Outcome Measures
Name Time Method Intra Ocular pressure (IOP) Month 24
- Secondary Outcome Measures
Name Time Method Intra Ocular pressure (IOP) day 1,week 1, and months 1, 3, 6, 9, 12 and 18 Changes in visual acuity day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24. Number of anti-glaucoma medications week 1, and months 1, 3, 6, 9, 12, 18, and 24 Mean deviation of visual field, week 1, and months 1, 3, 6, 9, 12, 18, and 24 Rate of intra- and postoperative complications week 1, and months 1, 3, 6, 9, 12, 18, and 24
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the pressure-regulating efficacy of Ahmed valve vs. Molteno single-plate implants in refractory glaucoma?
How does the 24-month comparative effectiveness of NCT00971061 implants align with standard-of-care trabeculectomy outcomes?
Which ocular biomarkers predict long-term success of glaucoma drainage devices in NCT00971061 refractory glaucoma patients?
What are the 24-month adverse event profiles for Ahmed valve and Molteno implants in NCT00971061 postoperative management?
How do combination therapies with anti-glaucoma medications impact outcomes in NCT00971061 device-treated refractory glaucoma?
Trial Locations
- Locations (1)
Vanak Eye Surgery Center
🇮🇷Tehran, Iran, Islamic Republic of