Secondary and Exploratory Outcomes of the Subthreshold Nanosecond Laser Intervention Randomized Trial in Age-Related Macular Degeneration: A LEAD Study Report
Zhichao Wu, Chi D Luu, Lauren AB Hodgson, Emily Caruso, Kate H Brassington, Nicole Tindill, Khin Zaw Aung, Colin A Harper, Sanjeewa S Wickremasinghe, Sukhpal S Sandhu, Myra B McGuinness, Fred K Chen, Usha Chakravarthy, Jennifer J Arnold, Wilson J Heriot, Shane R Durkin, Maximilian WM Wintergerst, Shekoufeh Gorgi Zadeh, Thomas Schultz, Robert P Finger Show all
OPHTHALMOLOGY RETINA | ELSEVIER INC | Published : 2019
PURPOSE: To evaluate the secondary and exploratory outcomes of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study, a 36-month trial of a subthreshold nanosecond laser (SNL) treatment for slowing the progression to late age-related macular degeneration (AMD) in its early stages. DESIGN: Multicenter, randomized, sham-controlled trial. PARTICIPANTS: Two-hundred ninety-two patients with bilateral large drusen. METHODS: Participants were randomly assigned to receive SNL or sham treatment to the study eye at 6-month intervals. MAIN OUTCOME MEASURES: The secondary outcome measure of the LEAD study was the time to development of late AMD, defined by multimodal im..View full abstract
Awarded by National Health & Medical Research Council of Australia
Supported by National Health & Medical Research Council of Australia (project grant APP1027624 [R.H.G. and C.D.L.], and fellowship grant GNT1103013 (R.H.G.), APP1104985 [Z.W.], APP1054712 [F.K.C.], APP1142962 [F.K.C.] and GNT1128343 [S.S.W.]), and BUPA Health Foundation (Australia) (R.H.G. and C.D.L.). The Centre for Eye Research Australia receives operational infrastructure support from the Victorian Government. Ellex R&D Pty Ltd. (Adelaide, Australia) provided partial funding of the central coordinating center and the in-kind provision of Ellex 2RT~ laser systems, ongoing support of those systems, and the Macular Integrity Assessment microperimeters for the duration of the study. The web-based Research Electronic Data Capture (REDCap) application and open-source platform OpenClinica allowed secure electronic data capture. The study is sponsored by the Centre for Eye Research Australia, an independent medical research institute and a not-for-profit company.