Baerveldt (BGI) Valve Versus Ahmed(AGV) Valve in Management of Difficult Glaucoma Cases
- Conditions
- Glaucoma SecondaryGlaucoma, Angle-ClosureGlaucoma, NeovascularGlaucoma, Open-Angle
- Interventions
- Device: glaucoma implant procedure (Ahmed)Device: glaucoma implant procedure (Baerveldt)
- Registration Number
- NCT04215575
- Lead Sponsor
- Ain Shams University
- Brief Summary
Refractory glaucoma is a difficult subject as many glaucoma devices attempt to reduce IOP. Baerveldt implant is considered as a large implant, and, on the contrary, Ahmed implant is considered a small implant as many comparisons have showed. Investigators have previously used two models S2 and FP7 Ahmed implant. Currently, investigators use Baerveldt implant in refractory glaucoma cases in order to compare it with the Ahmed implant.
- Detailed Description
Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP \> 21 mmHg were randomized for placement of Baerveldt implant or Ahmed implant models using a standardized surgical technique.
The primary outcome was failure, which was defined as IOP \>16 mmHg with glaucoma medication on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity, complications, and interventions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
1 - patients with glaucoma who underwent a previous failed trabeculectomy or other intraocular surgery.
2- patients who had secondary glaucoma and are known to have a high failure rate with trabeculectomy such as neovascular, uveitis, or iridocorneal endothelial syndrome-associated glaucoma, were included in the study.
1 - patients lacked light perception, unwilling or unable to give informed consent, were expected to be unavailable for follow-up visits.
2-had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
3- presence of silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
4-uveitis associated with a systemic condition like juvenile rheumatoid arthritis, nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGV model FP7 or S2 placement (AGV group) glaucoma implant procedure (Ahmed) A 184 mm2 Ahmed glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP \>16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits. The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures BGI model 101-350 placement (BGI group) glaucoma implant procedure (Baerveldt) A 350 mm2 Baerveldt glaucoma implant was placed. Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP \>16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures.
- Primary Outcome Measures
Name Time Method glaucoma medications one year follow up mean number of glaucoma medications
IOP one year follow up mean IOPs
- Secondary Outcome Measures
Name Time Method visual acuity one year follow up log MAR Snellen median and interquartile Range values