Trail design
IOL
SECONDARY, IOL
This protocol follows the Standard Protocol Items for Clinical Trials (SPIRIT 2013) [Study design: prospective, multicenter, superiority, parallel-group, single-blinded, and randomized controlled trialIntervention groups: consecutive eligible patients are randomized to undergo either secondary in-the-bag IOL implantation (capsular group) or secondary sulcus IOL implantation (sulcus group)Study flow chartStudy participants may have one or two study eyes. Study participants with two study eyes eligible will receive the same treatment. Further details on randomization are located in the “For both intervention groups, the surgeries are described in the “Sample sizeA minimum of 286 eyes (approximately 228 study participants assuming 75% have two study eyes)Duration of follow-upPrimary outcome: 1 yearTotal follow-up: 10 yearsFollow-up scheduleYears 1: follow-up visits occur 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year postoperativelyYears 2 to 10: follow-up visits occur every 6 months