Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey
|ClinicalTrials.gov Identifier: NCT01892943|
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : May 15, 2014
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.
|Condition or disease|
|Leber Hereditary Optic Neuropathy (LHON)|
|Study Type :||Observational|
|Actual Enrollment :||306 participants|
|Study Start Date :||August 2013|
|Primary Completion Date :||February 2014|
|Study Completion Date :||February 2014|
U.S. FDA Resources
|Patients with LHON|
- Visual acuity [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892943
|University Hospitals Leuven|
|Leuven, Belgium, 3000|
|Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology|
|Glostrup, Denmark, 2600|
|Bordeaux, France, 33000|
|CIC/CMR CHNO des Quinze-Vingts|
|Paris, France, 75012|
|Universty of Bari|
|Bari, Italy, 70100|
|Fondazione G.B. Bietti|
|Rome, Italy, 000199|
|San Raffaele Hospital|
|Segrate, Italy, 20132|
|University Eye Clinic|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Jose-Alain Sahel, MD||Centre de Recherche Institut de la Vision INSERMN|