Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT - Full Text View

Sponsor:	Singapore National Eye Centre
Collaborator:	National Medical Research Council (NMRC), Singapore
Information provided by:	Singapore National Eye Centre
ClinicalTrials.gov Identifier:	NCT00347178

Purpose

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	Intervention
Asymptomatic Narrow Angles Primary Angle Closure Suspects	Procedure: Laser Peripheral Iridotomy

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prophylactic Laser Iridotomy for Eyes With Narrow Drainage Angles; A Randomised Controlled Trial

Further study details as provided by Singapore National Eye Centre:

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

Estimated Enrollment:	544
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2013

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347178

Contacts

Contact: Tin - Aung, FRCSEd PhD

+65 63224581 ext -

Locations

Singapore
Singapore Eye Research Institute	Recruiting
Singapore, Singapore, 168751
Principal Investigator: Tin Aung, FRCSEd, PhD
Sub-Investigator: Steve KL Seah, FRCS (Ed)
Sub-Investigator: Paul TK Chew, FRCS (Ed)
Sub-Investigator: Hon T Wong, FRCS (Ed)
Sub-Investigator: Aliza - Jap, FRCOph (Lon)
Sub-Investigator: Kah G AuEong, FRCS (Ed)

Sponsors and Collaborators

Singapore National Eye Centre

National Medical Research Council (NMRC), Singapore

Investigators

Principal Investigator:

Tin - Aung, FRCSEd PhD

Singapoe National Eye Centre

More Information

No publications provided

Study ID Numbers:	R358/16/2004
Study First Received:	June 30, 2006
Last Updated:	June 30, 2006
ClinicalTrials.gov Identifier:	NCT00347178 History of Changes
Health Authority:	Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)

Keywords provided by Singapore National Eye Centre:

Asymptomatic Narrow Angles
Primary Angle Closure Suspects
Laser Peripheral Iridotomy
Randomised Controlled Trial

ClinicalTrials.gov processed this record on February 08, 2010