The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214847
• Other study ID #: FWA000017585 FMASU19/2017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2012
• Est. completion date: July 15, 2014

Study information

• Verified date: December 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 15, 2014
• Est. primary completion date: March 12, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Secondary
• Glaucoma, Neovascular
• Glaucoma, Open-Angle

Intervention

Procedure:
• Ahmed Glaucoma Valve surgery
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP .	All measurements of the postoperative mean IOPs at 12 months were compared with the baseline IOP .	one-year follow up