The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).
A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit
Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1
Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1
Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.
Any active ocular infection in either eye at either the Screening or Day 1 visits
Active sterile iritis or uveitis in either eye at Screening or Day 1 visits
Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)
Adult and adolescent subjects with qualifying LSCD
Cohort
Prospective
Non-interventional
Other interventionNon-interventional
Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes
Onset or changes (worsening or improving) in vision-related quality of life and ocular symptoms as captured with the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaires
Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA)
Change in photophobic BCVA
Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA)
Change in low-luminance BCVA
Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA)
Change in low-contrast BCVA
Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity)
Changes (onset, improvement, or worsening) in corneal sensitivity
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography/Tomography)
Changes (onset, improvement, or worsening) in corneal topography and/or tomography and/or densitometry
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency)
Changes (onset, improvement, or worsening) in epithelial defect frequency
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts)
Changes (onset, improvement, or worsening) in Palisades of Vogt crypts
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