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

Overview

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 Title of Study: “Baerveldt Glaucoma Implant Versus Ahmed Glaucoma Implant in One- Year Follow up, Comparative Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 1, 2016

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • IOP
    • Time Frame: one year follow up
    • mean IOPs
  • glaucoma medications
    • Time Frame: one year follow up
    • mean number of glaucoma medications

Secondary Measures

  • visual acuity
    • Time Frame: one year follow up
    • log MAR Snellen median and interquartile Range values

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: khaled hamdi elbaklish, principal investigator – Ain Shams University

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