Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT

Sponsor

Singapore National Eye Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT00347178

Collaborator

National Medical Research Council (NMRC), Singapore (Other)

544

Enrollment

Location

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asymptomatic Narrow Angles Primary Angle Closure Suspects	Procedure: Laser Peripheral Iridotomy	N/A

Detailed Description

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prophylactic Laser Iridotomy for Eyes With Narrow Drainage Angles; A Randomised Controlled Trial

Study Start Date :

Jan 1, 2005

Study Completion Date :

Jan 1, 2013

Outcome Measures

Primary Outcome Measures

Peripheral anterior synechiae formation []
IOP elevation >21 mm Hg []
Development of acute angle closure event []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Bilateral Narrow angles
Age 50 years and above
Informed consent obtained prior to or at baseline visit

Exclusion Criteria:

Presence of PAS
IOP > 21 mm Hg
Glaucomatous optic neuropathy and/or CDR > 0.7
Secondary angle closure such as uveitis, neovascularisation etc.
Prior intraocular surgery or penetrating eye injury
Corneal disorders such as corneal endothelial dystrophy except mild corneal guttae
Evidence of prior acute angle closure event
High risk of acute angle closure.
Significant cataract and visual acuity less than 20/40
Constant use of contact lens for refractive correction
Chronic use of topical or systemic steroids
Established retinopathies on ocular treatments (e.g. Diabetic)
Any other disease which is likely to cause field loss in next 3 years
Severe health problems decreasing life expectancy to less than one year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Singapore Eye Research Institute	Singapore		Singapore	168751

Sponsors and Collaborators

Singapore National Eye Centre
National Medical Research Council (NMRC), Singapore

Investigators

Principal Investigator: Tin - Aung, FRCSEd PhD, Singapoe National Eye Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00347178

Other Study ID Numbers:

R358/16/2004

First Posted:

Jul 4, 2006

Last Update Posted:

Jul 4, 2006

Last Verified:

Jun 1, 2006

Keywords provided by , ,

Asymptomatic Narrow Angles

Primary Angle Closure Suspects

Laser Peripheral Iridotomy

Randomised Controlled Trial

Study Results

No Results Posted as of Jul 4, 2006