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Intraocular Pressure (IOP) Lowering Effect of Selective Laser Trabeculoplasty Versus Prostaglandin Analogues in Angle Closure Glaucoma

NCT01004900 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-05-12

No results posted yet for this study

Summary

Glaucoma affects 66 million people worldwide and is the leading cause of irreversible blindness, and Primary angle-closure glaucoma (PACG) is a major form of glaucoma in Asia.

Laser peripheral iridotomy (LPI) has been advocated as the first line treatment in all cases of PACG. In addition to relieving the relative pupil block element of the condition, it can open up the drainage angle, alleviating appositional and synechial angle-closure and in the long-term this may control intraocular pressure (IOP) and prevent progression of glaucomatous optic neuropathy. 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.

Laser trabeculoplasty has been a recognized treatment option for Primary open angle glaucoma (POAG) since the 1980s. Recently a more selective and less destructive method of performing laser trabeculoplasty has evolved. Selective Laser Trabeculoplasty (SLT) specifically targets the pigmented trabecular meshwork cells without producing collateral damage and destruction to adjacent structures. Morphologic study performed on human autopsy eyes treated with SLT noted no structural or collateral thermal damage to the trabecular beams in the uveal and corneoscleral meshwork. As SLT specifically has its effect on the targeted pigmented trabecular meshwork it is unlikely to generate PAS. It may be a useful treatment option for PACG patients in whom the angle has widened following laser peripheral iridotomy.

The proposed study is a randomized controlled trial to assess the effectiveness of SLT in reducing IOP in cases of PACG in which the angle has opened up following LPI, but IOP remains high(\>21 mmHg). 100 subjects will be randomized to receive either SLT or medical treatment to achieve IOP control. They will be followed up for 6 months.

Conditions

Interventions

PROCEDURE

Selective Laser Trabeculoplasty

This is a laser procedure used to treat glaucoma by reducing the pressure in the eye. SLT works by using laser light to stimulate the body's own healing response to lower your eye pressure. Using a special wavelength and energy, the laser affects only pigmented (melanin containing) cells of your eye. SLT improves the flow of fluid in the eye, which in turn lowers your eye pressure.

DRUG

Travoprost/ Timolol/ Azopt/ Brimonidine

Travoprost (Topical eye drops) administered once daily before sleep

Sponsors & Collaborators

  • Singapore Eye Research Institute

    lead OTHER

Principal Investigators

  • Tin Aung, FRCOphth · Singapore National Eye Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Singapore

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 NCT01004900 on ClinicalTrials.gov