Condition category
Eye Diseases
Date applied
24/05/2017
Date assigned
27/07/2017
Last edited
27/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Photoreceptors are cells found at the back of the eye which convert light to an electric signal. They demand more energy than any other tissue in the body. Unfortunately, as people grow older, the energy-producing units in the cells (mitochondria) become less efficient and produce less energy. This is associated with inflammation which contributes to age-related macular degeneration (AMD) and aging in general. AMD is the most common cause of blindness in the elderly and unfortunately there is no prevention or cure for this. A molecule in the mitochondria can absorb a particular wavelength of light (670nm – which is red) and increase energy production. Studies have also shown that inflammation associated with aging and AMD is reduced by exposure to this red light. The aim of this study is to test whether exposure to 670 nm wavelength light can improve visual function in aging and AMD.

Who can participate?
Patients with dry AMD and healthy older people

What does the study involve?
Participants hold a device emitting red light to their eyes for two minutes every day for one year and their visual function is measured before, during and 1, 3, 6 and 12 months after this treatment.

What are the possible benefits and risks of participating?
This study will show whether exposure to 670 nm light can improve visual function in aging and AMD. There are no known risks.

Where is the study run from?
Moorfields Eye Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2017 to February 2019

Who is funding the study?
1. Moorfields Eye Charity (UK)
2. Fight for Sight (UK)

Who is the main contact?
Dr Chrishne Sivapathasuntharam

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chrishne Sivapathasuntharam

ORCID ID

Contact details

Institute of Ophthalmology
11 to 43 Bath Street
London
EC1V 9EL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REDA 15/0274

Study information

Scientific title

A pilot study to investigate the effect of 670 nm light on visual function in ageing and age-related macular degeneration

Acronym

Study hypothesis

Photoreceptors demand more energy than other tissue in the body. Unfortunately, as people grow older, mitochondria become less efficient and produce less energy. This is associated with inflammation which contributes to age-related macular degeneration (AMD) and aging in general. AMD is the commonest cause of blindness in the elderly and unfortunately, there is no prevention or cure for this.

A molecule in mitochondria can absorb a particular wavelength of light (670nm – which is red) and increase energy production. This has been shown in different cells, including the retina. Studies have also shown that inflammation associated with aging and AMD is reduced by exposure to this red light.

This is a pilot study to see if exposure to 670 nm wavelength of light can improve visual function in aging and AMD.

Ethics approval

London - Stanmore Research Ethics Committee, 24/01/2017, ref: 16/LO/2022

Study design

Pilot non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dry age-related macular degeneration

Intervention

Participants will hold a device emitting 670 nm light to their eyes for two minutes every day for one year and have their retinal function measured before, during and 1, 3, 6 and 12 months after.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Visual function determined by photoreceptor function over time, measured at 1, 3, 6 and 12 months

Secondary outcome measures

Measured at 1, 3, 6 and 12 months:
1. Metrics of photoreceptor function, assessed psychophysically and electrophysiologically
2. Visual acuity and low-luminance acuity
3. Light-adapted 30 Hz flicker peak time, measured using a RETeval device
4. Anatomical changes, evaluated using SD OCT, autofluorescence and colour photographs
5. Safety and compliance of 670 nm light exposure

Overall trial start date

01/01/2017

Overall trial end date

02/02/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with dry AMD and healthy aged subjects
2. Aged 50 years and above

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Co-existent ocular disease: any ocular condition is present such that, in the opinion of the investigator, might affect the inflammatory status, visual acuity or cone function during the course of the study
2. A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (e.g. cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal) and early cataract that might be susceptible to growth under the influence of 670 nm light
3. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following enrolment
4. Epilepsy
5. Allergies to adhesives or any other component used

Recruitment start date

29/03/2017

Recruitment end date

02/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
1st Floor Maple House (Suite B)
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Moorfields Eye Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fight for Sight

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2018/2019.

IPD sharing statement
The datasets generated during and/or analysed during the current study is not expected to be made available and will be held with the sponsor.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes