RecruitingNCT07195721

The Effect of PROSE or Scleral Lenses on Mental Health

The Effect of PROSE Treatment on Mental Health


Sponsor

Boston Sight

Enrollment

200 participants

Start Date

Nov 11, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is examining whether fitting patients with PROSE or scleral contact lenses (large specialty contact lenses that vault over the cornea and are filled with saline) for severe dry eye and other ocular surface diseases leads to improvements in mental health, including depression and anxiety. **You may be eligible if...** - You are 18 years of age or older - You are proceeding with a PROSE or scleral lens consultation for an ocular surface condition — such as dry eye disease, Sjögren's syndrome, graft-versus-host disease affecting the eye, Stevens-Johnson syndrome, chemical eye injury, or similar conditions - Your depression screening score (PHQ-9) is greater than 4 - Your eye symptoms score (OSDI) is 13 or higher **You may NOT be eligible if...** - Your eye symptoms score is below 13 - Your depression screening score is 4 or below - You are under 18 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

BostonSight

Needham, Massachusetts, United States

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NCT07195721


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