Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey
- Conditions
- Leber Hereditary Optic Neuropathy (LHON)
- Registration Number
- NCT01892943
- Lead Sponsor
- Santhera Pharmaceuticals
- Brief Summary
The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).
Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.
The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.
Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- patients with genetically confirmed diagnosis of LHON
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual acuity average 0 to 10 years (retrospective) The Entire duration of the disease patient by patient basis up to the date of completion of the Case Report Form (CRF).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
University Eye Clinic
🇸🇮Ljubljana, Slovenia
Fondazione G.B. Bietti
🇮🇹Rome, Italy
CIC/CMR CHNO des Quinze-Vingts
🇫🇷Paris, France
University Hospitals Leuven
🇧🇪Leuven, Belgium
San Raffaele Hospital
🇮🇹Segrate, Italy
Universty of Bari
🇮🇹Bari, Italy
CHU Bordeaux
🇫🇷Bordeaux, France
Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology
🇩🇰Glostrup, Denmark