The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

Ain Shams University

Status: Completed

Conditions: Glaucoma, Neovascular; Glaucoma Secondary; Glaucoma, Open-Angle

Treatments: Procedure: Ahmed Glaucoma Valve surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04214847

FWA000017585 FMASU19/2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery.
2. 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

1. 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,

2. patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.

3. patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.

4. patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis.

5. patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

polypropylene plate of Ahmed Glaucoma Valve

Experimental group

Description:

polypropylene plate of Ahmed Glaucoma Valve procedures were performed under local anesthesia except for children, general anesthesia was used. The polypropylene 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.

Treatment:

Procedure: Ahmed Glaucoma Valve surgery

silicone plate of Ahmed Glaucoma Valve

Active Comparator group

Description:

silicone plate of Ahmed Glaucoma Valve procedures were performed under local anesthesia except for children, general anesthesia was used. The silicone 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.

Treatment:

Procedure: Ahmed Glaucoma Valve surgery