Red Light Ptosis Proof-of-Concept

University College London (UCL)

Status: Enrolling

Conditions: Blepharoptosis; Mitochondrial Diseases

Treatments: Device: Near-infrared light

Study type: Interventional

Funder types: Other

Identifiers

NCT06292182

160802

58964 (Other Identifier)

332942 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Treatment start at baseline

Experimental group

Treatment:

Device: Near-infrared light

Delayed treatment start at 3 months from baseline

Experimental group

Treatment:

Device: Near-infrared light