Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563414
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa DEB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Natural History Study of Corneal Abrasions in Patients With Dystrophic Epidermolysis Bullosa DEB
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a non-interventional observational study that will evaluate the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa DEB Corneal abrasion symptomology frequency and outcomes will be evaluated for up to 6 months
Detailed Description:
The objective of this study is to characterize the natural history of corneal abrasions in patients with Dystrophic Epidermolysis Bullosa DEB Patients will be followed via remote weekly symptom diaries and monthly questionnaires to assess corneal abrasion symptoms frequency and duration
At designated clinical sites subjects may also have the option to participate in a concurrent substudy with clinical assessments including slit lamp exam with fluorescein staining imaging and measurement of visual acuity
Patients are followed for up to 6 months
At designated clinical sites subjects may also have the option to participate in a concurrent substudy with clinical assessments including slit lamp exam with fluorescein staining imaging and measurement of visual acuity
Patients are followed for up to 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None