Trial investigating the effect of a light-therapy sleep mask on the progression of advanced diabetic retinopathy
| ISRCTN | ISRCTN81658067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81658067 |
| Secondary identifying numbers | CZPPXV1.0 |
- Submission date
- 26/01/2016
- Registration date
- 28/01/2016
- Last edited
- 18/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Diabetes is a serious long-term condition where a person is unable to control their blood sugar (glucose). People living with diabetes often have to live with long-term complications of the disease. One of these complications is diabetic retinopathy, where the cells at the back of the eye (the retina) that are sensitive to light become damaged over time. This is because the mechanisms associated with diabetes can affect the oxygen supply to the retina, causing the cells to become starved of oxygen. In order to compensate for this, new blood vessels start to grow behind the retina. These blood vessels are generally very weak and prone to leakage, causing vision to deteriorate. Many of the people who suffer from diabetic retinopathy go on to develop a condition called diabetic macular edema (DME), if left untreated. This is where there is a build-up of fluid, blocking a tiny area in the centre of the retina called the macula, which is responsible for central vision (seeing what is directly ahead). Phototherapy (light therapy) is a type of treatment used to help people suffering from diabetic retinopathy. It works by wearing an eye mask to bed which delivers a precise amount of light into the eyes through closed eyelids (light-emitting sleep mask). This prevents the light-sensitive cells of the retina from adapting to the dark, so that during the night they do not require as much oxygen to work properly, helping to slow down the formation of new, weak blood vessels. The aim of this study is to find out whether wearing a light-emitting sleep mask to bed for 6 months can help to slow down the worsening of DME.
Who can participate?
Adults suffering from DME in either eye, which has caused the macula to swell to at least 220 microns in thickness
What does the study involve?
All participants are given a light-emitting sleep mask to wear every night for eight hours. The eye mask gives off a low intensity, green light which is shone onto closed eyelids during sleep. The eye mask is worn for one month, before it is returned so that the data can be analysed, and a new mask is provided so that the eye masks are worn for a total of 6 months. Participants have eye exams at the start of the study and then after 3 and 6 months to find out if wearing the mask has made any difference to their condition. Participants also complete a questionnaire about their experience of wearing the eye mask and have their blood sugar tested at the end of the study.
What are the possible benefits and risks of participating?
A potential benefit to participants is a significant and meaningful effect by a slowing, halting, or even reversing, of the progression of the patient's retinopathy. The risks of wearing the light mask are small. The light itself is very safe and the mask has undergone significant electrical testing. There does however, remain a small chance that patients could find the masks uncomfortable which may disturb sleep.
Where is the study run from?
Royal Vinohrady Teaching Hospital (Czech Republic)
When is the study starting and how long is it expected to run for?
January 2013 to October 2013
Who is funding the study?
1. Polyphotonix Ltd. (UK)
2. Elon Medical (Czech Republic)
Who is the main contact?
Dr Luke Barclay
Contact information
Public
Polyphotonix
Discovery 1
Netpark
Sedgefield
TS21 3FH
United Kingdom
Study information
| Study design | Single-centre prospective open-label non-randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Prospective open label clinical trial of a phototherapeutic eye mask for patients with diabetic retinopathy |
| Study objectives | Preventing retinal adaptation to darkness may alter disease progression. |
| Ethics approval(s) | Ethics committee of Vinohrady Teaching Hospital, 06/02/2013, ref: EK-VP/08/2013 1/2013 |
| Health condition(s) or problem(s) studied | Diabetic retinopathy |
| Intervention | All participants, having been screened and consented, are given a light-emitting sleep mask to be worn each night for 6 months. The masks emit a low intensity, green light (peak wavelength 504±5nm and intensity of 74±10cd/m^2) into their eyes through their closed eyelids for a maximum of 8 hours each night during sleep. The masks last for 1 month, at the end of which time they have to be returned (for analysis) and replaced. Initial and follow-up assessments are carried out at baseline, 3 and 6 months. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Best corrected visual acuity (VA) is assessed at a distance of 4 metres using ETDRS boards at baseline, 3 and 6 months 2. Macular thickness is assessed by spectral domain optical coherence tomography (OCT) at baseline, 3 and 6 months |
| Secondary outcome measures | 1. Compliance with treatment is assessed by mask usage time (recorded by the masks) after 6 months of use 2. Experience of use is assessed using a questionnaire (specially designed for the purpose of this study) after 6 months of use 3. Control of diabetes is assessed by measuring glycated haemoglobin (HbA1c) at baseline and 6 months |
| Overall study start date | 01/01/2013 |
| Completion date | 01/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Diabetic macular edema (DME) greater than 220um (central subfield thickness) in either eye |
| Key exclusion criteria | Patients presenting with significant coneal opacity that precludes OCT and fundus photography. |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 01/06/2013 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Prague
10034
Czech Republic
Sponsor information
Industry
Polyphotonix
Discovery 1, Netpark
Sedgefield
TS21 3FH
United Kingdom
"ROR" |
https://ror.org/02j3x9q40 |
|---|
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The investigators and sponsor intend to publish the findings of this trial in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/12/2017 | 18/01/2019 | Yes | No |
Editorial Notes
18/01/2019: Publication reference added
11/08/2017: Internal review.
