Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01892943

Enrollment

306

Registered

2013-07-08

Start date

2013-08-31

Completion date

2014-02-28

Last updated

2014-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leber Hereditary Optic Neuropathy (LHON)

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* patients with genetically confirmed diagnosis of LHON

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Belgium, Denmark, France, Italy, Slovenia

Outcome results