Clinical trial NCT04215575: Baerveldt (BGI) Valve Versus Ahmed(AGV) Valve in Management of Difficult Glaucoma Cases
Official title: Baerveldt Glaucoma Implant Versus Ahmed Glaucoma Implant in One- Year Follow up, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Glaucoma Secondary
Glaucoma, Neovascular
Glaucoma, Angle-Closure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 81
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to BGI model 101-350 placement (BGI group) or an AGV model FP7or S2 placement (AGV group). 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IOP
timeFrame: one year follow up
measure: glaucoma medications
timeFrame: one year follow up
Secondary outcomes:
measure: visual acuity
timeFrame: one year follow up
Other outcomes:
Locations:
Study officials:
References:
citation: Elbaklish KH, Saleh SM, Gomaa WA. Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study. Clin Ophthalmol. 2020 Jan 8;14:29-39. doi: 10.2147/OPTH.S224654. eCollection 2020.