Overview

Triamcinolone for Ahmed Glaucoma Valve

Status:
Unknown status

Trial end date:
2016-12-01

Target enrollment:
0

Participant gender:
All

Summary

This triple-blind, stratified, randomized clinical trial includes 100 eyes of 100 patients aged 18 to 85 years with refractory glaucoma. Eligible subjects undergo stratified block randomization; eyes are first stratified to one of four subgroups: group 1:patients with previous failed trabeculectomy, group 2: uveitic glaucoma, group 3: neovascular glaucoma and group 4: other indications like aphakic glaucoma or glaucoma associated with vitreoretinal procedures. In each subgroup, eyes are randomly assigned to the study arms using random blocks: conventional Ahmed Glaucoma Valve (AGV) implantation (group A, 50 eyes), Ahmed Glaucoma Valve (AGV) with intraoperative periplate triamcinolone injection (group B, 50 eyes). Patients will be followed for one year. They will undergo full ophthalmology examination at first day, first week, month 1, 3, 6, 9 and 12 after the surgery. The primary outcome measure is cumulative probability of success, defined as intraocular pressure (IOP) of 6-21 mm Hg, with or without medication, and no serious complications, additional glaucoma surgery, or loss of light perception. The outcomes will be compared between two arms in each subgroup. The number of eyes requiring medications, time to initiation of medications, and number of medications will be compared.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shahid Beheshti University of Medical Sciences

Treatments:

Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

- Eligible subjects were patients aged 18-85 years with refractory glaucoma scheduled
for AGV implantation.

Exclusion Criteria:

- Exclusion criteria was poor compliance for follow up, previous AGV implantation,
concomitant procedures such as deep vitrectomy or cataract surgery, and any major
intra- or postoperative complication which could affect the outcomes of surgery.

- Patients for whom AGV was implanted in any location except superior-temporal quadrant
were excluded.