The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

NCT04214847 | Completed

• 1 other identifier: FWA000017585 FMASU19/2017
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

glaucoma-ahmed-valve-S2-FP7-IOP-encapsulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

polypropylene plate of Ahmed Glaucoma Valve

EXPERIMENTAL

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.

Procedure: Ahmed Glaucoma Valve surgery

silicone plate of Ahmed Glaucoma Valve

ACTIVE COMPARATOR

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.

Procedure: Ahmed Glaucoma Valve surgery

Interventions

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.

polypropylene plate of Ahmed Glaucoma Valve; silicone plate of Ahmed Glaucoma Valve

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• Elbaklish KH, Gomaa WA. A One-Year Follow-Up of Two Ahmed Glaucoma Valve Models (S2 and FP7) for Refractory Glaucoma: A Prospective Randomized Trial. Clin Ophthalmol. 2020 Mar 4;14:693-705. doi: 10.2147/OPTH.S224653. eCollection 2020.

  PMID: 32184556 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Neovascular

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Coin test to choice the participants for both groups and reduce bias. Single surgeon ,highly expert in glaucoma to minimize unnecessary postoperative result changes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor in ophthalmology

Model Details: comparing clinical outcome variables (IOP, number of glaucoma medications, visual acuity, and complications) after using S2 and FP7 models of Ahmed Glaucoma Valves.

Study Record Dates

• First Submitted: December 22, 2019
• First Posted: January 2, 2020
• Study Start: February 1, 2012
• Primary Completion: March 12, 2014
• Study Completion: July 15, 2014
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share