Red Light Ptosis Proof-of-Concept

February 27, 2024 updated by: University College, London

Can Red Light Lift Droopy Eyelids? An Open-label Proof-of-concept Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment start at baseline
Device: Near-infrared light
daily application of near-infrared light
Experimental: Delayed treatment start at 3 months from baseline
Device: Near-infrared light
daily application of near-infrared light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Palpebral fissure width
Time Frame: 3 months from baseline
3 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Moorfields Eye Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160802
  • 332942 (Other Identifier: IRAS)
  • 58964 (Other Identifier: CPMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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