RECRUITING

The Effect of PROSE Treatment on Mental Health

Conditions

Depression - Major Depressive Disorder PROSE - prosthetic replacement of the ocular surface ecosystem

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of PROSE Treatment on Mental Health

Quick Facts

Study Start:2024-11-11

Study Completion:2029-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07195721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 -	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. Current or past PROSE or scleral lens wearer 13. Is an employee of BostonSight or an employee of a site performing the study -

Inclusion Criteria

Exclusion 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 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 -

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. Current or past PROSE or scleral lens wearer
13. Is an employee of BostonSight or an employee of a site performing the study -

Contacts and Locations

Study Contact

Estelle Crowley, BS

CONTACT

17817267506

ecrowley@bostonsight.org

Principal Investigator

Daniel Brocks, MD

PRINCIPAL_INVESTIGATOR

Boston Sight

Study Locations (Sites)

BostonSight

Needham, Massachusetts, 02494

United States

Collaborators and Investigators

Sponsor: Boston Sight

Daniel Brocks, MD, PRINCIPAL_INVESTIGATOR, Boston Sight

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11

Study Completion Date2029-10-31

Study Record Updates

Study Start Date2024-11-11

Study Completion Date2029-10-31

Terms related to this study

Keywords Provided by Researchers

PROSE - prosthetic replacement of the ocular surface ecosystem

Additional Relevant MeSH Terms

Depression - Major Depressive Disorder