Laser in Glaucoma and Ocular Hypertension Trial (LIGHT) in China -An Unmasked, Pragmatic Randomized Controlled Trial: Design and Baseline Characteristics

Abstract

Purpose : To establish whether initial treatment with selective laser trabeculoplasty (SLT) of patients with newly diagnosed open angle glaucoma (OAG) or ocular hypertension (OHT) is superior to current standard initial treatment with topical medication alone.

Methods : This is an unmasked, single-centric, clinic-imitating, randomized controlled Trial approved by the ethical committee of Zhongshan Ophthalmic Center, Sun Yat-sen University (2014MEKY054) and University College London (6334/002). Newly-diagnozed patients with OAG or OHT were divided into laser and medicine group randomly. The laser group received SLT firstly, and used conventional drugs when necessary. The medicine group only received medication. Primary outcome measurement is based on EQ-5D health related quality of life. Secondary outcome measurement includes treatment pathway cost, cost-effectiveness, glaucoma utility index (GUI), glaucoma symptom scale (GSS), glaucoma quality of life-15 (GQL-15), visual function, objective measure of pathway effectiveness and safety profiles, as well as compliance. Experimental design is basically the same as the sister study LiGHT Trial in UK, which had been published (BJO, 2017-310870), except several adaptions to remain within the medical practice framework in China.

Results : This RCT will recruit patients until December 31th, 2018. A total of 595 patients with OAG (645 eyes in mild stage, 295 eyes in moderate stage and 114 eyes in severe stage), and 143 patients with OHT were included from 2015 up to present. Both eyes in 575 patients were eligible. In the OAG patients, the mean age was 49.19±19.06, and 347 of them were male, 248 were female, with 97.98 % (583/595) were Han nationality. In the OHT patients, the mean age was 38.42±16.22. 70 male and 73 female were included in the OHT group with 97.20% (139/143) were Han nationality. 644 eyes of 367 patients received SLT, while 669 eyes of 371 patients received medical treatment. The median IOP was 20mmHg for the 1054 eyes OAG and 24 mmHg for the 259 OHT eyes.

Conclusions : LiGHT China Trial is the first RCT in China to compare the two treatment options in a real-world research and it will be meaningful to compare the data between LiGHT UK and China. The baseline characteristics of the LiGHT China cohort compare well with LiGHT UK cohort, as well as other landmark glaucoma studies.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.