At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome
In Brief
A clinical study evaluating Spectacles - Clinically Derived, Spectacles - Metric Technique #1 Derived, and 1 other intervention for Vision, Low. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.
Study Details
Timeline
Interventions
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.