PROSE or scleral lenses to improve mood in people with dry eye and other ocular surface disease
The Effect of PROSE Treatment on Mental Health
This project will test whether PROSE or scleral lenses help improve mood for adults with dry eye or other ocular surface disease who have symptoms of depression.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Boston Sight Academic / other |
| Locations | 1 site (Needham, Massachusetts) |
| Trial ID | NCT07195721 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study following adults undergoing PROSE or scleral lens fitting at BostonSight to see whether depressive symptoms change after treatment. Participants must have baseline dry eye symptoms (OSDI ≥13) and at least mild depressive symptoms (PHQ-9 >4), and will complete vision, ocular surface, and patient-reported outcome measures over time. PROSE uses customized rigid gas-permeable scleral lenses filled with preservative-free saline to protect and lubricate the ocular surface and improve vision. Investigators will analyze correlations between changes in ocular symptoms, visual function, and mental health scores.
Who should consider this trial
Good fit: Adults (18+) planning PROSE or scleral lens consultation for ocular surface disease who have at least mild depressive symptoms (PHQ-9 >4), an OSDI ≥13, can understand English, and can complete study visits are ideal candidates.
Not a fit: People without ocular surface disease or dry eye symptoms, those with PHQ-9 ≤4, or those who do not receive PROSE or scleral lenses are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce depressive symptoms and improve quality of life for people whose mood is linked to painful or vision-limiting ocular surface disease.
How similar studies have performed: Prior studies have reported associations between dry eye and depression, but direct evidence that PROSE or scleral lenses improve mental health is limited, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written Informed Consent has been obtained prior to any study-related procedures taking place. 2. Subject is Male or Female, 18 years of age or older prior to the initial visit. 3. Patient is proceeding with a PROSE or scleral lens consultation in one or both eyes for the primary diagnosis of ocular surface disease, including but not limited to Ocular Graft vs Host Disease, Keratoconjunctivitis Sicca, Dry eye, Sjogren's Disease, Rheumatologic ocular surface disease, Exposure Keratitis, Limbal Stem Cell Deficiency, Steven Johnson Syndrome, Mucous Membrane Pemphigoid (Ocular Cicatricial Pemphigoid), Atopic Keratoconjunctivitis, Chemical injury. 4. Baseline PHQ-9 score \> 4 5. Baseline OSDI score of 13 or greater 6. In the opinion of the investigator, the subject can follow study instructions, complete all study procedures and visits 7. Is able to understand the English language in verbal and written interactions - Exclusion Criteria: 1. Is currently participating in any other type of eye-related clinical research study that in the opinion of the investigator would interfere with the study 2. Is pregnant or nursing as reported by the subject. 3. Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study. 4. Recently started medication or other therapeutic treatments for affective mood disorders (such as depression) within the last 8 weeks. 5. Recently started new treatment for ocular surface disease, including but not limited to topical medicated drops, procedures, punctal plugs within the last 8 weeks. 6. Ocular surgery within the last 8 weeks 7. Planned ocular surgery within the study period 8. Has a known allergy to topical ophthalmic sodium fluorescein dye 9. Has a known intolerance to topical ophthalmic normal saline 10. Neurotrophic Keratitis 11. Corneal ectasia 12. PROSE or scleral lens wearer within the last 1 year prior to Visit 1 \[subjects who have solely tried a PROSE or scleral lens in an office setting consultation (and were never dispensed for home use) ARE eligible for enrollment, regardless of whether it occurred in the last year\] 13. Is an employee of BostonSight or an employee of a site performing the study -
Where this trial is running
Needham, Massachusetts
- BostonSight — Needham, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Brocks, MD — Boston Sight
- Study coordinator: Estelle Crowley, BS
- Email: ecrowley@bostonsight.org
- Phone: 17817267506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.