Clinical Trial

The Effect of PROSE or Scleral Lenses on Mental Health

Recruiting
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Summary
The goal of this prospective clinical trial is to evaluate the effect that prosthetic replacement of the ocular surface ecosystem (PROSE, BostonSight, Needham MA) treatment may have on mental health, particularly affective mood disorders. Correlation between changes in mental health and ocular symptom improvement and/or visual function improvement will be evaluated.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-25; most recent amendment 2025-12-30.
Trial Details
NCT Number NCT07195721
Lead Sponsor Boston Sight
Conditions Depression - Major Depressive Disorder
Enrollment 200 participants
Start Date 2024-11-11
Primary Completion 2029-10-31 (estimated)
Study Completion 2029-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-05