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Argon Laser Peripheral Iridoplasty for Primary Angle Closure Glaucoma

NCT00980473 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-06-17

No results posted yet for this study

Summary

Glaucoma is the leading cause of irreversible blindness worldwide. With ageing of the population, glaucoma morbidity will rise, causing increased health care costs and economic burden for a condition in which visual loss, once established, cannot be reversed. In contrast to western countries, primary angle closure glaucoma (PACG) is a major form of glaucoma in Asia. In a recent population based survey in Singapore, the prevalence of glaucoma was 3.2% in the Chinese population over 40. Glaucoma was the leading cause of blindness, with PACG the most visually destructive form of the disease.

Laser iridotomy is the current first line treatment for PACG. It acts by relieving pupil block, which in turn may reduce intraocular pressure (IOP) and prevent progression of glaucoma. However recent data indicate that iridotomy is not successful in controlling IOP in the long term, and the majority of cases develop a clinically significant rise in IOP requiring medical therapy or surgery.

Argon laser peripheral iridoplasty (ALPI) offers a new therapeutic option for PACG. The procedure consists of placing contraction burns in the iris periphery which results in contraction of the iris stroma and opening of the angle.

The proposed study is a 2-centre randomized controlled trial to determine whether ALPI is an effective and safe treatment in the management of PACG. 210 patients with PACG and high IOP (\>21 mmHg) following laser iridotomy will be randomized to receive ALPI or medical treatment to achieve IOP control. Subjects will be followed up for 12 months and the outcome criteria will be the rate of medical treatment and surgery in each group, and the angle width and configuration.

This will be the first RCT worldwide to address the role of ALPI in PACG. The study findings will have great relevance for the prevention of glaucoma blindness in the elderly.

Conditions

Interventions

PROCEDURE

Argon Laser Iridoplasty

DRUG

Travatan/ Timolol/Azopt

Sponsors & Collaborators

  • National University Hospital, Singapore

    collaborator OTHER

  • Singapore National Eye Centre

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-09-30

Countries

  • Singapore

Study Locations

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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 NCT00980473 on ClinicalTrials.gov