Design and Methodology of a Randomized Controlled Trial of Laser Iridotomy for the Prevention of Angle Closure in Southern China: The Zhongshan Angle Closure Prevention Trial

Abstract

Purpose: To summarize the design and methodology of a large-scale trial in southern China, the Zhongshan Angle Closure Prevention (ZAP) trial. This trial will determine if laser iridotomy (LI) is superior to no treatment for managing Chinese people who are Primary Angle Closure Suspects (PACS). In this trial, PACS was defined as having 6 or more clock hours of angle circumference in which the pigmented trabecular meshwork was not visible under static gonioscopy in both eyes without elevated intraocular pressure, peripheral anterior synechiae or glaucomatous neuropathy.

Methods: Subjects were recruited from an urban district in Guangzhou. The target sample size was 870. Persons 50 years of age and older with 20/40 or better vision in both eyes identified as having 6 or more clock hours of angle circumference in which the pigmented trabecular meshwork was not visible under static gonioscopy in both eyes were enrolled. Each subject was randomized to undergo LI in one eye with the fellow eye left untreated. Follow up is planned for a minimum period of 3 years. Baseline examination included tonometry, limbal chamber depth grading, gonioscopy, fundus photography, anterior segment coherence tomography, ultrasound A scan, ultrasound biomicroscopy, specular microscopy and dark room provocative testing. Endpoints for the study include developing elevated intraocular pressure, peripheral anterior synechiae or experiencing acute primary angle closure.

Conclusion: The ZAP trial will determine if LI is safe and effective at preventing pathological angle closure in asymptomatic eyes with narrow angle configurations on gonioscopy. It will also provide data on what happens to untreated eyes in PACSs. Data collected at baseline will also help identify those at high risk for developing primary angle closure and primary angle closure glaucoma.

KEYWORDS::

• angle-closure glaucoma
• laser iridotomy
• methodology
• randomized controlled trial
• study design

ACKNOWLEDGMENTS

This study was supported by Fight for Sight (UK) and the Sun Yat-sen University 5010 Project Fund from China. Dr. Foster’s work is supported in part by an award from the National Institute for Health Research (UK) to Moorfields Eye Hospital and UCL Institute of Ophthalmology for the Biomedical Research Centre for Ophthalmology and from the RD Crusaders Trust (via Fight for Sight).

Declaration of Interest: Dr. M. He has received an instrument loan (YAG laser) from Carl Zeiss Meditec.