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Triamcinolone for Ahmed Glaucoma Valve

NCT02653963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-06-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Adjunctival Triamcinolone

Intraoperative Periplate 10 mg Triamcinolone Injection during AGV Implantation

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Principal Investigators

  • Azadeh Doozandeh, MD · Ophthalmology research center, Shahid Beheshti University Of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-04-30
Completion
2016-12-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653963 on ClinicalTrials.gov