Analyses of the reporting status and scope of current interventions for pediatric strabismus trials within the National Library of Medicine

Background: Pediatric strabismus (PS) is one of the most common conditions for referrals to an ophthalmologist, with a worldwide prevalence of nearly 6%. Untreated strabismus may lead to amblyopia and irreversible decreased vision. Research through clinical trials is necessary to advance treatment options, thus our primary objective was to assess PS trials using the CDC’s Clinical Trial Database. Additionally, our secondary objective was to assess rates of PS trial discontinuation.

Methods: We performed a search of the U.S. National Library of Medicine’s Clinical Trials Database (clinicaltrials.gov) on October 8, 2024, to capture interventional clinical trials that included children. We collated trials by completion status and reported rates of the type of strabismus assessed, intervention type, trial phase, enrollment, location, and funding source.

Results: Of the 204 trials returned from the search, 77 met the inclusion criteria. Of the trials, the most frequent type of strabismus examined was exotropia (32, 41.6%) followed by general strabismus (24, 31.2%), and esotropia (12, 15.6%) and the most common interventions used were surgical (33, 42.9%) and devices (22, 28.6%). Egypt had the most registered PS trials (21, 27.3%) followed by the United States (20, 26.0%). Of the included trials, only 3 (3.9%) trials had been discontinued

Discussion: Our results showed that surgical interventions for PS were the most common intervention used and that few PS studies have been discontinued. Additionally, Egypt and the United States had the highest rates of registered PS clinical trials. Our study highlights the range of current clinical trials to help inform physicians and caregivers of individuals with PS.