NCT07195721Recruiting
The Effect of PROSE or Scleral Lenses on Mental Health
The Effect of PROSE Treatment on Mental Health
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 25 Sept 2025
- Start date
- 11 Nov 2024
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Boston Sight
- Diseases
- Depression
- NCT number
- NCT07195721
What you commit to
- Study type: Observational
- Planned participants: 200
- From 11 Nov 2024 to the primary completion date, 31 Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ocular surgery within the last 8 weeks
- Planned ocular surgery within the study period
- PROSE or scleral lens wearer within the last 1 year prior to Visit 1 \[subjects who have solely tried a PROSE or scleral lens in an office setting consultation (and were never dispensed for home use) ARE eligible for enrollment, regardless of whether it occurred in the last year\]
Other illness
- 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.
Lab values
- Has a known allergy to topical ophthalmic sodium fluorescein dye
Other
- 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 known intolerance to topical ophthalmic normal saline
- Neurotrophic Keratitis
- Corneal ectasia
- Is an employee of BostonSight or an employee of a site performing the study -
Who the study is looking for
- Written Informed Consent has been obtained prior to any study-related procedures taking place.
- Subject is Male or Female, 18 years of age or older prior to the initial visit.
- 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.
- Baseline PHQ-9 score \> 4
- Baseline OSDI score of 13 or greater
- In the opinion of the investigator, the subject can follow study instructions, complete all study procedures and visits
- Is able to understand the English language in verbal and written interactions -
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BostonSight Coordinator of this site? Confirm its status | Needham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.