Evaluation of the diagnostic parameters of the amblyopia and risk factors for amblyopia screening protocol in 3-year-olds according to recommendations from the French Association for Pediatric Ophthalmology and Strabismus (AFSOP) compared with reference ophthalmological examination: the ORTHOPHTALMO study.

Introduction: The ORTHOPHTALMO study aims to evaluate the diagnostic parameters of the screening protocol for amblyopia and risk factors for amblyopia in 3-year-olds recommended in 2019 by the French Association for Pediatric Ophthalmology and Strabismus (AFSOP). This protocol uses visual acuity, photoscreening refraction, and cover test examination performed by an orthoptist. Patient referral to an ophthalmologist is only according to recommended referral criteria. Methods: A prospective, single-center study was performed between September 2020 and June 2021 on a consecutive series of 3-year-olds consulting the Ophthalmology Centre of Clinique Rive Gauche, Toulouse, France, for vision screening. Patients were first examined by an orthoptist following the screening protocol recommended by AFSOP. All patients were then systematically examined by an ophthalmologist for cycloplegic refraction measurement (reference examination). The ophthalmologist was blinded to the referral conclusion and refraction measurements of the orthoptist. Results: A total of 300 patients (149 girls and 151 boys) were included. Examination by an orthoptist was unreliable/incomplete in 7% of cases. An abnormality was detected by the orthoptist in ≥1 of the screening tests among 42% of patients; these patients were thus considered as requiring referral to an ophthalmologist. Reference ophthalmological examination found 41% of patients required treatment. The diagnostic parameters of this screening protocol were 90% for sensitivity and 89% for specificity. Discussion: We validate the effectiveness and feasibility of the AFSOP screening protocol for detection of amblyopia and risk factors for amblyopia in 3-year-olds as well as the recommended criteria for referral to an ophthalmologist.ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04395560.Number: NCT04395560.