| Popis: |
Background: Treatment of pediatric cataract remains challenging because of extremely high incidence of postoperative adverse events (AEs), especially, the AEs related to the locations of secondary implanted intraocular lens (IOL). There are two common locations for secondary IOL implantation in pediatric aphakic eyes: ciliary sulcus or in-the-bag implantation. However, there are currently no large, prospective, studies comparing complication rates and visual prognosis of in-the-bag versus ciliary-sulcus secondary IOL implantation in pediatric patients. Whether or how much secondary in-the-bag IOL implantation benefits the pediatric patients more than sulcus implantation and deserves to be performed routinely by surgeons remain to be elucidated. Here we describe the protocol of a randomized controlled trial (RCT) designed to evaluate the safety and efficacy of two approaches of IOL implantation in pediatric aphakia. Methods: The study is a multicenter, single-blinded RCT. Overall, a minimum of 284 eyes (approximately 228 participants assuming 75% have two study eyes) will be recruited. This study will be carried out in four eye clinics across China. Consecutive eligible patients are randomized to undergo either: secondary in-the-bag IOL fixation or secondary sulcus IOL fixation. Participants with two eyes eligible will receive the same treatment. The primary outcome is the incidence of glaucoma-related AEs by 1-year postoperatively. The secondary outcomes include incidence of other AEs, IOL decentration and tilt, visual acuity and ocular refractive power. Analysis of the primary and secondary outcomes is to be based on the intentiontotreat principle. Statistical analyses will includeχ 2 test or Fisher’s exact test for the primary outcome; Mixed model and GEE (Generalized estimated equation) model for the secondary outcome; Kaplan-Meier survival curves for the cumulative probability of glaucoma-related AEs over time in each group. Discussion: To the best of our knowledge, this study is the first RCT to evaluate the safety and efficacy of secondary IOL implantation in pediatric aphakia. The results will provide high-quality evidence for the clinical guidelines of the treatment of pediatric aphakia. Trial registration: ClinicalTrials.gov, NCT05136950. Registered on 1 November 2021 |
