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
This trial does not accept healthy volunteersQualifiers
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 population
Patients who are being evaluated for PROSE or scleral lens treatment.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Patients who are considering PROSE treatment for ocular surface disease
Trial outcomes
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.
Time frame
At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispenseSecondary outcomes
1
Ocular Surface Disease Index (OSDI) questionnaire
The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate,and severe) and effect on vision-related function. The minimum score on the OSZDZI is 0 and the maximum score is 100 which indicates greater disability dues to dry eye disease.
Time frame
At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispense2
Visual Function Questionnaire 25 (VFQ25)
Measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The minimum score on the VFQ25 is 0 and the maximum score is 100 with higher scores indicating better visual function and health status.
Time frame
At enrollment, 28 days post PROSE dispense and 84 days post PROSE dispenseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov