The Effect of PROSE or Scleral Lenses on Mental Health (NCT07195721)
The Effect of PROSE Treatment on Mental Health
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (14 items).
Location: BostonSight — Needham, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
- Is pregnant or nursing as reported by the subject.
- 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.
- Recently started medication or other therapeutic treatments for affective mood disorders (such as depression) within the last 8 weeks.
- Recently started new treatment for ocular surface disease, including but not limited to topical medicated drops, procedures, punctal plugs within the last 8 weeks.
- Ocular surgery within the last 8 weeks
- Planned ocular surgery within the study period
- Has a known allergy to topical ophthalmic sodium fluorescein dye
- Has a known intolerance to topical ophthalmic normal saline
- Neurotrophic Keratitis
- Corneal ectasia
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- BostonSight — Needham, Massachusetts
📞 Contact the Study Coordinator
Phone: (781) 726-7506
Email: ecrowley@bostonsight.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.