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Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT

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ClinicalTrials.gov Identifier: NCT00347178
Recruitment Status : Unknown
Verified June 2006 by Singapore National Eye Centre.
Recruitment status was:  Recruiting
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by:
Singapore National Eye Centre

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date July 4, 2006
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • Peripheral anterior synechiae formation
  • IOP elevation >21 mm Hg
  • Development of acute angle closure event
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT
Official Title  ICMJE Prophylactic Laser Iridotomy for Eyes With Narrow Drainage Angles; A Randomised Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Asymptomatic Narrow Angles
  • Primary Angle Closure Suspects
Intervention  ICMJE Procedure: Laser Peripheral Iridotomy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June 30, 2006)
544
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2013
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347178
Other Study ID Numbers  ICMJE R358/16/2004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Singapore National Eye Centre
Collaborators  ICMJE National Medical Research Council (NMRC), Singapore
Investigators  ICMJE
Principal Investigator: Tin - Aung, FRCSEd PhD Singapoe National Eye Centre
PRS Account Singapore National Eye Centre
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP