Triamcinolone for Ahmed Glaucoma Valve

NCT02653963 | Completed

• 1 other identifier: ShaheedBMU-9467
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Glaucoma

Keywords

Steroid, Triamcinolone, Ahmed Glaucoma valve

Outcome Measures

Primary Outcomes (1)

• INTRAOCULAR PRESSURE

  Intraocular pressure (IOP) of 6-21 mm Hg, with or without medication, and no serious complication

  1, 3, 6 ,9 and 12 month

Secondary Outcomes (2)

• Anti-glaucoma drug number

  1, 3, 6 ,9 and 12 month

• Visual acuity

  1, 3, 6 ,9 and 12 month

Study Arms (2)

Conventional AGV

NO INTERVENTION

A limbus-based conjunctival peritomy was created 4mm posterior to the limbus and Tenon's capsule was dissected. The AGV Plate was secured to the sclera 8 mm posterior to the limbus. The tube was trimmed to an appropriate length and inserted into the anterior chamber through a corneoscleral track. The tube was fixed to the episclera with a 10-0 nylon mattress suture. A donor sclera was fashioned to cover the exposed part of the tube and was secured to the sclera using 10-0 nylon sutures. The conjunctiva and Tenon were closed using 10-0 nylon suture.

Triamcinolone adjuctival AGV

EXPERIMENTAL

Subtenon Periplate 10 mg triamcinolone acetonide around the AGV plate after fixation of AGV Plate to the sclera

Drug: Adjunctival Triamcinolone

Interventions

Adjunctival Triamcinolone DRUG

Intraoperative Periplate 10 mg Triamcinolone Injection during AGV Implantation

Also known as: Intraoperative steroid

Triamcinolone adjuctival AGV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, 16666, Iran

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Azadeh Doozandeh, MD

  Ophthalmology research center, Shahid Beheshti University Of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ShaheedBMU

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 13, 2016
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

IR (1)