NCT06292182

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2024

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

February 27, 2024

Last Update Submit

February 27, 2024

Conditions

Mitochondrial DiseasesBlepharoptosis

Outcome Measures

Primary Outcomes (1)

  • Palpebral fissure width

    3 months from baseline

Study Arms (2)

Treatment start at baseline

EXPERIMENTAL
Device: Near-infrared light

Delayed treatment start at 3 months from baseline

EXPERIMENTAL
Device: Near-infrared light

Interventions

Near-infrared lightDEVICE

daily application of near-infrared light

Delayed treatment start at 3 months from baselineTreatment start at baseline

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Mitochondrial DiseasesBlepharoptosis

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesEyelid DiseasesEye Diseases

Central Study Contacts

Glen Jeffery, PhD

CONTACT

020 7608 6800g.jeffery@ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 5, 2024

Study Start

February 8, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

March 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)