About this trial
This study is a non-interventional, observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa (DEB).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject or their respective legal guardian must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent/Assent Form and must be able to and willing to follow study procedures and instructions.
Age 6 months or older at time of Informed Consent/Assent.
Prior genetic diagnosis of DEB due to mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
Disqualifiers
None
Trial population
Patients with Dystrophic Epidermolysis Bullosa, aged 6 months or older.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Corneal abrasion frequency
Frequency of corneal abrasion symptoms
Secondary outcomes
Epidermolysis Bullosa Eye Disease Index Symptom Score
Symptom score for Epidermolysis Bullosa related eye problems, 0 to 30 (higher score indicates worse symptoms)
Sponsors and contacts
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