The Effect of PROSE or Scleral Lenses on Mental Health

NCT07195721 | Recruiting

• 1 other identifier: MH-2024-DB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder

Keywords

PROSE - prosthetic replacement of the ocular surface ecosystem

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire 9 (PHQ9)

  The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. The minimum score on the PHQ9 is 0 and the maximum score is 27 which indicates the most severe depression.

  At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense

Secondary Outcomes (2)

• Ocular Surface Disease Index (OSDI) questionnaire

  At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense

• Visual Function Questionnaire 25 (VFQ25)

  At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense

Study Arms (1)

Patients who are considering PROSE treatment for ocular surface disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are being evaluated for PROSE or scleral lens treatment.

You may qualify if:

• 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 -

You may not qualify if:

• 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
• PROSE or scleral lens wearer within the last 1 year prior to Visit 1 \[subjects who have solely tried a PROSE or scleral lens in an office setting consultation (and were never dispensed for home use) ARE eligible for enrollment, regardless of whether it occurred in the last year\]
• Is an employee of BostonSight or an employee of a site performing the study -

Sponsors & Collaborators

• Boston Sight: lead

Study Sites (1)

BostonSight

Needham, Massachusetts, 02494, United States

RECRUITING

Study Officials

• Daniel Brocks, MD

  Boston Sight

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estelle Crowley, BS

CONTACT

17817267506; ecrowley@bostonsight.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: September 29, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-10

Locations

US (1)