Baerveldt (BGI) Valve Versus Ahmed(AGV) Valve in Management of Difficult Glaucoma Cases

Not Applicable

Completed

• Conditions: Glaucoma Secondary; Glaucoma, Angle-Closure; Glaucoma, Neovascular; Glaucoma, Open-Angle

• 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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-20
• Status Verified: 2019-12
• Study First Submitted: 2019-12-29
• Study First Submitted QC: 2019-12-31
• Last Update Submitted: 2019-12-31
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

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.

Exclusion Criteria

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

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