Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT

Singapore National Eye Centre544 enrolled

Overview

This is a multicentric, randomised, controlled study comparing Laser Iridotomy (LI) to no treatment in subjects with asymptomatic narrow angles (ANA).One eye of each subject with ANA will be randomised to undergo LI and the other eye will be left alone and will serve as an internal control. Subjects are proposed to be followed up once a year for 5 years.

Objective: This study will compare LI versus no treatment in subjects with asymptomatic narrow angles, the anatomical trait that predisposes to primary angle closure glaucoma (PACG), in order to assess the effectiveness of prophylactic treatment in the prevention of blindness due to PACG. Eligibility: 1. Bilateral Narrow angles; 2. Age 50 years and above; 3. Informed consent obtained prior to or at baseline visit. Trial Design: Subjects with asymptomatic ANA undergoes randomisation after comprehensive ocular exam followed by randomisation to LI in one eye and no treatment in the other eye. Follow up is done for 5 years with yearly examination.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

544

Conditions

Asymptomatic Narrow Angles Primary Angle Closure Suspects

Interventions

Laser Peripheral IridotomyPROCEDURE

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Bilateral Narrow angles 2. Age 50 years and above 3. Informed consent obtained prior to or at baseline visit Exclusion Criteria: 1. Presence of PAS 2. IOP \> 21 mm Hg 3. Glaucomatous optic neuropathy and/or CDR \> 0.7 4. Secondary angle closure such as uveitis, neovascularisation etc. 5. Prior intraocular surgery or penetrating eye injury 6. Corneal disorders such as corneal endothelial dystrophy except mild corneal guttae 7. Evidence of prior acute angle closure event 8. High risk of acute angle closure. 9. Significant cataract and visual acuity less than 20/40 10. Constant use of contact lens for refractive correction 11. Chronic use of topical or systemic steroids 12. Established retinopathies on ocular treatments (e.g. Diabetic) 13. Any other disease which is likely to cause field loss in next 3 years 14. Severe health problems decreasing life expectancy to less than one year.

Locations (1)

Singapore Eye Research Institute

Singapore, Singapore

RECRUITING

Outcomes

Primary Outcomes

Peripheral anterior synechiae formation

IOP elevation >21 mm Hg

Development of acute angle closure event

Secondary Outcomes

Changes in the grading of Modified Schaffer Grading

Development of glaucomatous optic neuropathy

Development of corresponding visual field loss by automated perimetry

Change in HRT optic disc parameters

Change in UBM angle parameters

Formation of disc pallor

Central Contacts

Tin - Aung, FRCSEd PhD

CONTACT

+65 63224581

Data from ClinicalTrials.gov

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