A multicentre phase III randomised controlled single-masked clinical trial to test the clinical efficacy and safety of LightMasks at preventing dark adaptation in the treatment of non-centre-involving diabetic macular oedema

Moorfields Eye Hospital NHS Foundation Trust (UK)0 sites300 target enrollmentFebruary 18, 2014

Overview

Registry

who.int

Start Date

February 18, 2014

End Date

November 30, 2016

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Moorfields Eye Hospital NHS Foundation Trust (UK)

•1\. Subjects of either sex aged 18 years or over
•2\. Diagnosis of diabetes mellitus (type 1 or type 2\). Any one of the following will be considered to be sufficient evidence that diabetes is present:
•2\.1\.Current regular use of insulin for the treatment of diabetes
•2\.2\. Current regular use of oral antihyperglycaemic agents for the treatment of diabetes
•2\.3\. Documented diabetes by ADA and/or WHO criteria
•3\. Best corrected visual acuity in the study eye better than 55 ETDRS letters (Snellen VA 6/18\).
•4\. On clinical exam, retinal thickening due to early DMO not involving the central 100 µm of the macula characterised by presence of microaneurysm, exudates or oedema and OCT evidence of increased retinal thickness in at least 1 noncentral ETDRS zone of \=320 µm.
•5\. Previous macular laser, intravitreal steroids or anti\-VEGF treatment is permitted provided the last laser was done at least 4 months before date of recruitment.
•6\. Media clarity, pupillary dilation and subject cooperation sufficient for adequate fundus photographs
•7\. Ability to return for study visits

•The following exclusions apply to the study eye only (i.e. they may be present for the non study eye):
•1\. Centre\-involving macular oedema defined as central subfield on OCT \>300 um.
•2\. Macular oedema is considered to be due to a cause other than DMO.
•3\. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, IrvineGass syndrome, etc).
•4\. History of treatment for DMO at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti\-VEGF drugs, or any other treatment) in the study eye
•5\. History of panretinal scatter photocoagulation in the study eye.
•6\. Active proliferative diabetic retinopathy in the study eye.
•7\. A condition that, in the opinion of the investigator, would preclude participation in the study.
•8\. Patients with history of insomnia or any other sleep disturbances.
•9\. Corneal scarring, vitreous opacities, severe asteroid hyalosis that would inhibit proper visualisation, inability to be positioned in front of the OCT device, inability to understand the requirements of the imaging, and nystagmus.