The Effect of PROSE or Scleral Lenses on Mental Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBoston Sight
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov