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

Ain Shams University

Status: Completed

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

Treatments: Device: glaucoma implant procedure (Ahmed); Device: glaucoma implant procedure (Baerveldt)

Study type: Interventional

Funder types: Other

Identifiers

NCT04215575

FWA000017585 FMASU21/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

BGI model 101-350 placement (BGI group)

Active Comparator group

Description:

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.

Treatment:

Device: glaucoma implant procedure (Baerveldt)

AGV model FP7 or S2 placement (AGV group)

Experimental group

Description:

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

Treatment:

Device: glaucoma implant procedure (Ahmed)