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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06292182
Other study ID # 160802
Secondary ID 33294258964
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2024
Est. completion date November 30, 2025

Study information

Verified date February 2024
Source University College, London
Contact Glen Jeffery, PhD
Phone 020 7608 6800
Email g.jeffery@ucl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study tests a new treatment to help with droopy eyelids (ptosis) and eye movement problems (squint) in children and young people with genetically confirmed mitochondrial conditions - using red-light. We use a torch to shine a red light through the closed eyelid for 3 minutes a day. The study will run for 18 months. We believe that this treatment could help strengthen the muscle in the eyelid to make it easier to open the eyes, and could also help some children with squint.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date November 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion: Age 3 to less than 18 years Genetically confirmed diagnosis of primary mitochondrial disease (known pathogenic mutation(s) in mitochondrial or nuclear DNA known to cause primary mitochondrial disease) Ptosis Exclusion: Genetic diagnosis not consistent with primary mitochondrial disease. No genetic diagnosis Unable to cooperate with light treatment or ophthalmological assessments.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Near-infrared light
daily application of near-infrared light

Locations

Country Name City State
United Kingdom Moorfields Eye Hospital NHS Foundation Trust London

Sponsors (2)

Lead Sponsor Collaborator
University College, London Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Palpebral fissure width 3 months from baseline
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