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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 February 2019 |
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Main ID: |
ISRCTN81658067 |
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Date of registration:
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28/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial investigating the effect of a light-therapy sleep mask on the progression of advanced diabetic retinopathy
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Scientific title:
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Prospective open label clinical trial of a phototherapeutic eye mask for patients with diabetic retinopathy |
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Date of first enrolment:
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01/03/2013 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN81658067 |
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Study type:
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Interventional |
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Study design:
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Single-centre prospective open-label non-randomised clinical trial (Treatment)
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Phase:
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Countries of recruitment
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Czech Republic
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Contacts
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Name:
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Luke
Barclay |
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Address:
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Polyphotonix
Discovery 1
Netpark
TS21 3FH
Sedgefield
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Aged 18 years or over
2. Diabetic macular edema (DME) greater than 220um (central subfield thickness) in either eye
Exclusion criteria: Patients presenting with significant coneal opacity that precludes OCT and fundus photography.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic retinopathy
Eye Diseases
Moderate proliferative, or non-proliferative retinopathy and progressive Diabetic Macular Edema (DME)
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Secondary ID(s)
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CZPPXV1.0
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Source(s) of Monetary Support
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Polyphotonix Ltd., Elon Medical
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Ethics review
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Status:
Approval date:
Contact:
Ethics committee of Vinohrady Teaching Hospital, 06/02/2013, ref: EK-VP/08/2013 1/2013
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/10/2013 |
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URL:
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