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Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01892943
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : May 15, 2014
European Vision Institute Clinical Research Network
Information provided by (Responsible Party):
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.

Condition or disease
Leber Hereditary Optic Neuropathy (LHON)

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Study Type : Observational
Actual Enrollment : 306 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Patients with LHON

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with genetically confirmed diagnosis of LHON

Inclusion Criteria:

  • patients with genetically confirmed diagnosis of LHON

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01892943

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University Hospitals Leuven
Leuven, Belgium, 3000
Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology
Glostrup, Denmark, 2600
CHU Bordeaux
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
Sponsors and Collaborators
Santhera Pharmaceuticals
European Vision Institute Clinical Research Network
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Principal Investigator: Jose-Alain Sahel, MD Centre de Recherche Institut de la Vision INSERMN
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Responsible Party: Santhera Pharmaceuticals Identifier: NCT01892943    
Other Study ID Numbers: LHON HCR
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Atrophy, Hereditary, Leber
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases