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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02376725
Other study ID # R796/80/2010
Secondary ID
Status Completed
Phase N/A
First received February 12, 2015
Last updated February 25, 2015
Start date June 2011
Est. completion date February 2015

Study information

Verified date February 2015
Source Singapore National Eye Centre
Contact n/a
Is FDA regulated No
Health authority Singapore: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if phacoemulsification with intraocular lens implant (phaco/IOL) alone or combined with goniosynechialysis is better at controlling intraocular pressure in subjects with primary angle closure.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Phaco/IOL
Phaco/IOL refers to extracapsular cataract extraction (using phacoemulsification) and intraocular lens implantation
Phaco/IOL + goniosynechialysis
Phaco/IOL refers to extracapsular cataract ectraction (using phacoemulsification) and intraocular lens implantation. Goniosynechialysis refers to mechanical breaking of peripheral anterior synechiae using a spatula and goniolens to view the drainage angle structures.

Locations

Country Name City State
Singapore Singapore National Eye centre Singapore

Sponsors (3)

Lead Sponsor Collaborator
Singapore National Eye Centre National Medical Research Council (NMRC), Singapore, Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular pressure as measured by Goldmann applanation tonometry 1 year No
Secondary Per-operative and post-operative complications as determined by the examining/operating clinician 1 year Yes
Secondary Peripheral anterior synechiae development as measured by gonioscopy 1 year No
Secondary Degree of angle opening as measured by gonioscopy and anterior segment ocular coherence tomography 1 year No
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