REALITY LHON Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-03

Study Completion Date

2020-07-01

Brief Summary

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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).

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Detailed Description

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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

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Leber Hereditary Optic Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Single-group study

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).

Patient-reported outcomes (PROs)

Intervention Type OTHER

Patient-reported outcomes (PROs)

Interventions

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Patient-reported outcomes (PROs)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects who have a confirmed and genotyped diagnosis of LHON;
* Subjects with visual function outcomes data including at least 2 visual function assessments between 1 year and 3 years (+/- 4 weeks) after vision loss;
* Subjects who are willing and able to provide written informed consent if required as per local regulations;
* For LHON subjects under the age of 18 years, permission from a legal guardian to participate in the study;

Exclusion Criteria

* Subjects who received any investigational drug, or participated in any LHON-related interventional clinical trial during the observational period;
* Subjects without medical charts data available.

Eligible Sex

ALL

Accepts Healthy Volunteers

No