Pediatric Strabismus Clinical Trial Analysis and Reporting Statuses within the National Library of Medicine

Authors

  • Von Gray Oklahoma State University College of Osteopathic Medicine at Cherokee Nation, Office of Medical Student Research, Tahlequah, Oklahoma
  • Austin Young Oklahoma State University College of Osteopathic Medicine at Cherokee Nation, Office of Medical Student Research, Tahlequah, Oklahoma
  • Dawsyn Smith Oklahoma State University College of Osteopathic Medicine at Cherokee Nation, Office of Medical Student Research, Tahlequah, Oklahoma
  • Stephen Groves, M.D.
  • Micah Hartwell, Ph.D. Oklahoma State University College of Osteopathic Medicine at Cherokee Nation, Office of Medical Student Research, Tahlequah, Oklahoma; Oklahoma State University Center for Health Sciences, Department of Psychiatry and Behavioral Sciences, Tulsa, Oklahoma

Abstract

Background: Pediatric strabismus (PS) is one of the most common conditions for referral to an ophthalmologist, with a worldwide prevalence of nearly 6%. Untreated strabismus leads to amblyopia and irreversible decreased vision. Research through clinical trials (CTs) is necessary to advance treatment options. Our primary objective was to summarize current characteristics of PS CTs using the United States National Library of Medicine’s (NLM) Clinical Trial Database, providing an overview of current treatments. Our secondary objective was to assess rates of PS trial discontinuation. 

Methods: We searched the NLM’s Clinical Trials Database (ClinicalTrials.gov) on October 8, 2024, to capture interventional CTs that included children. We collated trials by completion status and reported rates of type of strabismus assessed, intervention type, trial phase, enrollment, location, and funding source. 

Results: Of 204 trials returned from the search, 77 met inclusion criteria. Of the trials, the most frequent type of strabismus was exotropia (32, 41.6%) followed by general strabismus (24, 31.2%), and esotropia (12, 15.6%). The most common interventions 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 included trials, 3 (3.9%) had been discontinued. 

Conclusions: Surgical interventions for PS were the most common intervention used and many completed trials lack reported results in the database. Egypt and the United States had the highest rates of registered PS CTs. Our study highlights the range of current CTs to help inform physicians and caregivers of individuals with PS. 

 

Keywords: pediatric; strabismus; intervention; treatment; surgery; research waste

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Published

2026-05-14

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Section

Medical