PROSE or scleral lenses to improve mood in people with dry eye and other ocular surface disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.