NCT07195721 The Effect of PROSE or Scleral Lenses on Mental Health
| NCT ID | NCT07195721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Sight |
| Condition | Depression - Major Depressive Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-11-11 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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 -
Contact & Investigator
Daniel Brocks, MD
PRINCIPAL INVESTIGATOR
Boston Sight
Frequently Asked Questions
Who can join the NCT07195721 clinical trial?
This trial is open to participants of all sexes, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07195721 currently recruiting?
Yes, NCT07195721 is actively recruiting participants. Contact the research team at ecrowley@bostonsight.org for enrollment information.
Where is the NCT07195721 trial being conducted?
This trial is being conducted at Needham, United States.
Who is sponsoring the NCT07195721 clinical trial?
NCT07195721 is sponsored by Boston Sight. The principal investigator is Daniel Brocks, MD at Boston Sight. The trial plans to enroll 200 participants.
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