CompletedNot Applicable

REALITY LHON Registry

United States44 participantsStarted 2018-01-03

Plain-language 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).

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Visual Function

Timeframe: All assessments available before enrollment

The National Eye Institute Visual Function Questionnaire (VFQ)-25

Timeframe: Enrollment

The 36-Item Short Form Health Survey (SF-36)

Timeframe: Enrollment

Child Health Questionnaire (CHQ)

Timeframe: Enrollment

EuroQol-5 Dimension (EQ-5D)-5L

Timeframe: Enrollment

Trial details

NCT IDNCT03295071

SponsorGenSight Biologics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-07-01

View on ClinicalTrials.gov More Leber Hereditary Optic Neuropathy trials