An interventional study of Patching and Prism Adaptation in Exotropia, sponsored by University of Rochester. Terminated at 9 sites in 5 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's enrollment of 1 is below the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
Procedure: Patching
Procedure: Prism Adaptation
The subject will occlude the non-dominant eye for 24 hours.
The subject will undergo prism adaptation targeting the pre-occlusion distance angle for 1-2 weeks. • Fresnel prism(s) will be applied to the patient's spectacles equaling the distance angle between the two eyes. At the examiner's discretion depending on the size of the deviation, the prism(s) can be placed solely over the non-dominant eye, or split between the 2 eyes in some combination which results in equalization of the distance exotropia. If the distance angle calls for an amount of prism that cannot be exactly replicated with Fresnel prisms (e.g., 32 PD), the amount of prism used will be determined by rounding down to the nearest practical amount at examiner discretion.
Percent of participants reclassified as divergence excess exotropia
Percentage of patients with distance and near exotropia measurements within 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Time frame: 2 weeks
Percent of participants reclassified as simulated divergence excess exotropia
Percentage of patients with distance and near exotropia measurements differing by more than 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Time frame: 2 weeks
Plan to share: No
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This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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