The Effect of PROSE or Scleral Lenses on Mental Health
Recruiting · NCT07195721 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boston Sight
View the official record on ClinicalTrials.gov →What this trial is about
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 take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 -
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
- 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 -
Where it is running
1 location listed across 1 US state.
- BostonSight - Needham, Massachusetts, United States