TY - JOUR
T1 - Laser peripheral iridotomy for the prevention of angle closure
T2 - a single-centre, randomised controlled trial
AU - He, Mingguang
AU - Jiang, Yuzhen
AU - Huang, Shengsong
AU - Chang, Dolly S.
AU - Munoz, Beatriz
AU - Aung, Tin
AU - Foster, Paul J.
AU - Friedman, David S.
N1 - Funding Information:
This work is supported by the Fight for Sight (grant 1655 ; UK), the Sun Yat-sen University 5010 Project Fund (grant 2007033 ; China), the National Natural Science Foundation of China (grant 81420108008 ; China), Fundamental Research Funds of the State Key Laboratory in Ophthalmology (China) and Moorfields Eye Charity (previously Special Trustees of Moorfields Eye Hospital). MH receives support from the University of Melbourne Research at Melbourne Accelerator Program Professorship. The Centre for Eye Research Australia receives operational infrastructural support from the Victorian government. YJ and PJF are supported by a grant from the British Council for Prevention of Blindness. PJF received additional support from the National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital, London, UK (NIHR-BRC2 009; Moorfields/UCL-IOO), and the Richard Desmond Charitable Foundation (via Fight for Sight UK). These funding sources did not play any role in the design and conduct of the study, the collection, management, analysis, or interpretation of the data, the preparation, review, or approval of the manuscript, or the decision to submit the manuscript for publication. We thank all the ZAP participants and experts in the trial steering committee (alphabetically Augusto Azuara-Blanco [Belfast, UK], Nathan G Congdon [Belfast, UK], Sir Peng T Khaw [co-chair; London, UK], Winifred P Nolan [London, UK], Harry A Quigley [co-chair; Baltimore, MD, USA], Ravi Thomas [Brisbane, Australia], Richard Wormald [London, UK]), advisory committee (Jian Ge, Gus Gazzard [London, UK], Dennis Lam [Hong Kong, China], Jeffrey M Liebmann [New York, NY, US], Robert Ritch [New York, NY, USA], Xing-Huai Sun [Shanghai, China], Clement Tham [Hong Kong, China], Ningli Wang [Beijing, China], Liang Xu [Nanjing, China], Jia-Liang Zhao [Beijing, China]), data monitoring and safety committee (Keith Barton [London, UK], Don Budenz, [Chapel Hill, NC, USA], Maureen McGuire, [Philadelphia, PA, USA], Jim Tielsch [chair; Baltimore, MD, USA]), and all our research staff for recruitment and facilitating follow-up.
Publisher Copyright:
© 2019 Elsevier Ltd
PY - 2019/4/20
Y1 - 2019/4/20
N2 - Background: Primary angle-closure glaucoma affects 20 million people worldwide. People classified as primary angle closure suspects have a higher but poorly quantified risk of developing glaucoma. We aimed to assess efficacy and safety of laser peripheral iridotomy prophylaxis against primary angle-closure glaucoma in Chinese people classified as primary angle closure suspects. Methods: In this randomised controlled trial, bilateral primary angle closure suspects aged 50–70 years were enrolled at the Zhongshan Ophthalmic Center, a tertiary specialised hospital in Guangzhou, China. Eligible patients received laser peripheral iridotomy in one randomly selected eye, with the other remaining untreated. The primary outcome was incident primary angle closure disease as a composite endpoint of elevation of intraocular pressure, peripheral anterior synechiae, or acute angle-closure during 72 months of follow-up in an intention-to-treat analysis between treated eyes and contralateral controls. This trial is registered with the ISRCTN registry, number ISRCTN45213099. Findings: Of 11 991 screened individuals, 889 individuals were randomly assigned from June 19, 2008 (889 treated and 889 untreated eyes). Incidence of the primary outcome was 4·19 per 1000 eye-years in treated eyes compared with 7·97 per 1000 eye-years in untreated eyes (hazard ratio 0·53; 95% CI 0·30–0·92; p=0·024). A primary outcome event occurred in 19 treated eyes and 36 untreated eyes with a statistically significant difference using pair-wise analysis (p=0·0041). No serious adverse events were observed during follow-up. Interpretation: Incidence of angle-closure disease was very low among individuals classified as primary angle closure suspects identified through community-based screening. Laser peripheral iridotomy had a modest, albeit significant, prophylactic effect. In view of the low incidence rate of outcomes that have no immediate threat to vision, the benefit of prophylactic laser peripheral iridotomy is limited; therefore, widespread prophylactic laser peripheral iridotomy for primary angle-closure suspects is not recommended. Funding: Fight for Sight, the Sun Yat-Sen University 5010 Project Fund, Moorfields Eye Charity, and the National Natural Science Foundation of China.
AB - Background: Primary angle-closure glaucoma affects 20 million people worldwide. People classified as primary angle closure suspects have a higher but poorly quantified risk of developing glaucoma. We aimed to assess efficacy and safety of laser peripheral iridotomy prophylaxis against primary angle-closure glaucoma in Chinese people classified as primary angle closure suspects. Methods: In this randomised controlled trial, bilateral primary angle closure suspects aged 50–70 years were enrolled at the Zhongshan Ophthalmic Center, a tertiary specialised hospital in Guangzhou, China. Eligible patients received laser peripheral iridotomy in one randomly selected eye, with the other remaining untreated. The primary outcome was incident primary angle closure disease as a composite endpoint of elevation of intraocular pressure, peripheral anterior synechiae, or acute angle-closure during 72 months of follow-up in an intention-to-treat analysis between treated eyes and contralateral controls. This trial is registered with the ISRCTN registry, number ISRCTN45213099. Findings: Of 11 991 screened individuals, 889 individuals were randomly assigned from June 19, 2008 (889 treated and 889 untreated eyes). Incidence of the primary outcome was 4·19 per 1000 eye-years in treated eyes compared with 7·97 per 1000 eye-years in untreated eyes (hazard ratio 0·53; 95% CI 0·30–0·92; p=0·024). A primary outcome event occurred in 19 treated eyes and 36 untreated eyes with a statistically significant difference using pair-wise analysis (p=0·0041). No serious adverse events were observed during follow-up. Interpretation: Incidence of angle-closure disease was very low among individuals classified as primary angle closure suspects identified through community-based screening. Laser peripheral iridotomy had a modest, albeit significant, prophylactic effect. In view of the low incidence rate of outcomes that have no immediate threat to vision, the benefit of prophylactic laser peripheral iridotomy is limited; therefore, widespread prophylactic laser peripheral iridotomy for primary angle-closure suspects is not recommended. Funding: Fight for Sight, the Sun Yat-Sen University 5010 Project Fund, Moorfields Eye Charity, and the National Natural Science Foundation of China.
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U2 - 10.1016/S0140-6736(18)32607-2
DO - 10.1016/S0140-6736(18)32607-2
M3 - Article
C2 - 30878226
AN - SCOPUS:85064327097
SN - 0140-6736
VL - 393
SP - 1609
EP - 1618
JO - The Lancet
JF - The Lancet
IS - 10181
ER -