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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04214847
Other study ID # FWA000017585 FMASU19/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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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Study Design


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
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