Red Light Ptosis Proof-of-Concept

NCT ID: NCT06292182

Last Updated: 2024-03-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mitochondrial Diseases Blepharoptosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment start at baseline

Group Type EXPERIMENTAL

Near-infrared light

Intervention Type DEVICE

daily application of near-infrared light

Delayed treatment start at 3 months from baseline

Group Type EXPERIMENTAL

Near-infrared light

Intervention Type DEVICE

daily application of near-infrared light

Interventions

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Near-infrared light

daily application of near-infrared light

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Exclusion: Genetic diagnosis not consistent with primary mitochondrial disease. No genetic diagnosis Unable to cooperate with light treatment or ophthalmological assessments.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Glen Jeffery, PhD

Role: CONTACT

020 7608 6800

Facility Contacts

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Annegret H Dahlmann-Noor, PhD

Role: primary

020 7253 3411

Other Identifiers

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332942

Identifier Type: OTHER

Identifier Source: secondary_id

58964

Identifier Type: OTHER

Identifier Source: secondary_id

160802

Identifier Type: -

Identifier Source: org_study_id

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