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Search / Trial NCT04215575

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

Launched by AIN SHAMS UNIVERSITY · Dec 31, 2019

Trial Information

Current as of May 15, 2025

Completed

Keywords

ClinConnect Summary

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.

Gender

ALL

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.

About Ain Shams University

Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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