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Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT

NCT ID: NCT00347178

Last Updated: 2006-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asymptomatic Narrow Angles Primary Angle Closure Suspects

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Laser Peripheral Iridotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role collaborator

Singapore National Eye Centre

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Tin - Aung, FRCSEd PhD

Role: PRINCIPAL_INVESTIGATOR

Singapoe National Eye Centre

Locations

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Singapore Eye Research Institute

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Tin - Aung, FRCSEd PhD

Role: CONTACT

Phone: +65 63224581

References

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Baskaran M, Kumar RS, Friedman DS, Lu QS, Wong HT, Chew PTK, Lavanya R, Narayanaswamy A, Perera SA, Foster PJ, Aung T. The Singapore Asymptomatic Narrow Angles Laser Iridotomy Study: Five-Year Results of a Randomized Controlled Trial. Ophthalmology. 2022 Feb;129(2):147-158. doi: 10.1016/j.ophtha.2021.08.017. Epub 2021 Aug 26.

Reference Type DERIVED
PMID: 34453952 (View on PubMed)

Narayanaswamy A, Baskaran M, Tun TA, Htoon HM, Aung T. Effect of Pharmacological Pupil Dilatation on Angle Configuration in Untreated Primary Angle Closure Suspects: A Swept Source Anterior Segment Optical Coherence Tomography Study. J Glaucoma. 2020 Jul;29(7):521-528. doi: 10.1097/IJG.0000000000001506.

Reference Type DERIVED
PMID: 32224802 (View on PubMed)

Other Identifiers

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R358/16/2004

Identifier Type: -

Identifier Source: org_study_id