NCT03295071

REALITY LHON Registry

Observational Registry Study of Leber Hereditary Optic Neuropathy (LHON) Affected Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: GenSight Biologics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a multi-country retrospective and cross-sectional observational study of affected LHON subjects, based on retrospective subjects' medical chart abstractions and cross-sectional administration of patient-reported outcomes (PROs).

Detailed description

The purpose of this study is to understand the evolution of visual functional and structural changes and other associated symptoms in patients with LHON. The relation between genetic, lifestyle and/or environmental factors and the LHON disease will be described, and a better understanding of the natural history of LHON disease and the healthcare associated to with the disease will be sought. In addition, we would also like to understand the economic burden for patients and their families with LHON resulting from direct and indirect costs they may have because of their disease.

Conditions

• Leber Hereditary Optic Neuropathy

Interventions

Type	Name	Description
OTHER	Patient-reported outcomes (PROs)	Patient-reported outcomes (PROs)

Timeline

• Start date: 2018-01-03
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2017-09-27
• Last updated: 2026-03-02

Locations

11 sites across 5 countries: United States, France, Italy, Spain, United Kingdom