The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

The clinical difference (mean IOP, success rate, and complications) on using S2 and FP7 models of Ahmed Glaucoma Valve that had similar dimensions and different materials used for their construction in one year follow up was evaluated.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Glaucoma Secondary Glaucoma, Neovascular Ocular Hypertension

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Refractory glaucoma is a difficult subject; many glaucoma devices are tried to reduce IOP. Glaucoma devices is now an integral part of glaucoma surgery. AGV is commonly used. The investigators need to compare the efficiency and failure rate of two models of AGV. The point that is the biological reaction around capsule can affect the efficiency.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery.
patients had secondary glaucoma known to have a high failure rate with trabeculectomy such as neovascular, uveitis, post keratoplasty glaucoma or iridocorneal endothelial syndrome-associated glaucoma.

Exclusion criteria

patients lacked light perception, unwilling or unable to give informed consent, lived out of the area and were expected to be unavailable for follow-up visits,
patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis.
patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.

Treatment and study plan

Ahmed Glaucoma Valve surgery

Procedure

The surgical procedure was identical for both implant types and was performed as described previously.9,14 All surgical procedures were performed under local anesthesia except for children, general anesthesia was used. The valve plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.

Primary outcomes

the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP .

Time frame: one-year follow up

All measurements of the postoperative mean IOPs at 12 months were compared with the baseline IOP .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

One- Year Follow up of Two Models of Ahmed Glaucoma Valves (S2 and FP7) in Refractory Glaucoma

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 2, 2020
Registry last updated: Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed