Actively Recruiting
The Effect of PROSE or Scleral Lenses on Mental Health
Led by Boston Sight · Updated on 2026-01-05
200
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of PROSE or Scleral Lenses on Mental Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study procedures
- Male or female aged 18 years or older before the first visit
- Undergoing PROSE or scleral lens consultation for ocular surface disease such as Ocular Graft vs Host Disease, Keratoconjunctivitis Sicca, Dry eye, Sjogren's Disease, and related conditions
- Baseline PHQ-9 score greater than 4
- Baseline Ocular Surface Disease Index score of 13 or higher
- Able to follow study instructions and complete all procedures and visits
- Able to understand spoken and written English
You will not qualify if you...
- Currently participating in another eye-related clinical research that may interfere with this study
- Pregnant or nursing
- Condition or situation posing significant risk or interfering with study participation as judged by investigator
- Started new medication or treatment for mood disorders within the last 8 weeks
- Started new treatment for ocular surface disease within the last 8 weeks
- Had ocular surgery within the last 8 weeks
- Planned ocular surgery during the study period
- Known allergy to topical ophthalmic sodium fluorescein dye
- Known intolerance to topical ophthalmic normal saline
- Neurotrophic Keratitis
- Corneal ectasia
- PROSE or scleral lens wearer within the last year prior to first visit, except those who only had office consultations without home use
- Employee of BostonSight or study site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BostonSight
Needham, Massachusetts, United States, 02494
Actively Recruiting
Research Team
E
Estelle Crowley, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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