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

Baerveldt Glaucoma Implant Versus Ahmed Glaucoma Implant in One- Year Follow up, Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Glaucoma, Neovascular; Glaucoma Secondary
• Intervention / Treatment: Device: glaucoma implant procedure (Baerveldt); Device: glaucoma implant procedure (Ahmed)

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BGI model 101-350 placement (BGI group); 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.	Device: glaucoma implant procedure (Baerveldt); A 350 mm2 Baerveldt glaucoma implant was placed in the superotemporal quadrant in 25 patients randomized to BGI group. A limbus-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.; Other Names: glaucoma valve surgery
Experimental: AGV model FP7 or S2 placement (AGV group); 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	Device: glaucoma implant procedure (Ahmed); A 184 mm2 Ahmed glaucoma implant was placed in the superotemporal quadrant in 56 patients randomized to AGV group. A fornix-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. The Ahmed tube left patent and viscoelastic substance injected into anterior chamber. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.; Other Names: glaucoma valve surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	mean IOPs	one year follow up
glaucoma medications	mean number of glaucoma medications	one year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity	log MAR Snellen median and interquartile Range values	one year follow up

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 20, 2016

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular; Glaucoma, Angle-Closure
• Other Study ID Numbers: FWA000017585 FMASU21/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no actual plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No