Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT

June 30, 2006 updated by: Singapore National Eye Centre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

544

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168751
        • Recruiting
        • Singapore Eye Research Institute
        • 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)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Collaborators

National Medical Research Council (NMRC), Singapore

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

January 1, 2013

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2006

Last Update Submitted That Met QC Criteria

June 30, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R358/16/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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