Recruiting NCT07636590
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-interventional.
- Who it may be relevant to
- Registry conditions: Limbal Stem Cell Deficiency. Basic parameters: 12 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Overview
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).
Interventions
- Other Non-interventional
Non-interventional
Primary outcome measures
- Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes [Time frame: Screening through Week 84]
- Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA) [Time frame: Screening through Week 84]
- Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA) [Time frame: Screening through Week 84]
- Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA) [Time frame: Screening through Week 84]
- Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity) [Time frame: Screening through Week 84]
- Natural Progression of LSCD as Assessed by Anatomical/Structural Changes [Time frame: Screening through Week 84]
Secondary outcome measures (7)
- Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity) [Time frame: Screening through Week 84]
- Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography/Tomography) [Time frame: Screening through Week 84]
- Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency) [Time frame: Screening through Week 84]
- Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts) [Time frame: Screening through Week 84]
- Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial and Total Corneal Thickness) [Time frame: Screening through Week 84]
- Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus) [Time frame: Screening through Week 84]
- Changes that May be Correlated with LSCD as Assessed by Changes Ocular and Systemic Health Outcome Measures [Time frame: Screening through Week 84]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Note: Other inclusion/exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- Claris Investigative Site — Carmel
- Claris Investigative Site — Indianapolis
- Claris Investigative Site — Overland Park
- Claris Investigative Site — Louisville
- Claris Investigative Site — Minnetonka
- Claris Investigative Site — Portland
- Claris Investigative Site — Smyrna
- Claris Investigative Site — San Antonio
Identifiers
NCT: NCT07636590 · CSB-C26-001