Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Asymptomatic Narrow Angles Primary Angle Closure Suspects||Procedure: Laser Peripheral Iridotomy||Not Applicable|
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 (Clinical Trial)|
|Enrollment :||544 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylactic Laser Iridotomy for Eyes With Narrow Drainage Angles; A Randomised Controlled Trial|
|Study Start Date :||January 2005|
|Study Completion Date :||January 2013|
- Peripheral anterior synechiae formation
- IOP elevation >21 mm Hg
- Development of acute angle closure event
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347178
|Contact: Tin - Aung, FRCSEd PhD||+65 63224581|
|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)|
|Principal Investigator:||Tin - Aung, FRCSEd PhD||Singapoe National Eye Centre|