Metabolomics Analysis According to the Thickness of the Retinal Nerve Fiber Layer in Patients With NOHL Mutations

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Leber hereditary optic neuropathy (LHON), due to mitochondrial DNA (mtDNA) mutations, is responsible for profound visual impairment. However, there is evidence that optic nerve damage begins before vision declines. There is no biomarker to determine when optic nerve damage begins before visual acuity decline occurs. We hope that the analysis of metabolomics will reveal specific metabolomic profiles and different vitamin B3 and B9 levels depending on whether there are OCT signs of optic nerve damage in healthy patients with mtDNA mutations suggestive of LHON (11778, 3460 or 14484). The existence of an increase in the thickness of the optic fiber layer, whose normal values are well established, constitutes such a sign in favor of optic nerve damage.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• Patient carrying an mtDNA mutation suggestive of NOHL (11778, 3460 or 14484) with normal visual acuity and who has never had optic neuropathy, or Patient not carrying an mtDNA mutation suggestive of NOHL (11778, 3460 or 14484) with normal visual acuity and who has never had optic neuropathy;

• Patient agreeing to undergo an OCT;

• Patient agreeing to sign the informed consent;

• Patient affiliated to French social protection (Primary Health Insurance Fund, CMU, etc.) or European social protection.

Locations
Other Locations
France
HEGP
RECRUITING
Paris
Contact Information
Primary
christophe Orssaud, MD
christophe.orssaud@aphp.fr
33 +156093466
Backup
Pascal Reynier, MD PhD
PaReynier@chu-angers.fr
Time Frame
Start Date: 2023-03-10
Estimated Completion Date: 2026-03-10
Participants
Target number of participants: 90
Treatments
Other: Two arms will be constituted according to gender and crossed according to OCT data
Considering the difference in NOHL prevalence in men and women, with a sex ratio of 7 men to 3 women, the metabolomic analysis data will be analyzed according to gender and OCT data.
Sponsors
Leads: Hôpital Necker-Enfants Malades

This content was sourced from clinicaltrials.gov