NCT01892943

Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: Santhera Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Leber Hereditary Optic Neuropathy (LHON)

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-07-08
• Last updated: 2014-05-15

Locations

8 sites across 5 countries: Belgium, Denmark, France, Italy, Slovenia