The Effect of PROSE or Scleral Lenses on Mental Health

Part of paid clinical trials in Needham, Massachusetts.

Sponsor
Boston Sight
Study ID
NCT07195721
Status
Recruiting
Apply to this trial

Conditions

  • Depression - Major Depressive Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
Oct 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Patients who are considering PROSE treatment for ocular surface disease

Primary Outcome Measure

Patient Health Questionnaire 9 (PHQ9) [ Time Frame: At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BostonSightNeedhamMassachusetts02494
Estelle Crowley, BS
[email protected]
7817267506
[email protected]
Daniel Brocks, MD (PRINCIPAL_INVESTIGATOR)

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BostonSight· Needham, MA

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