Light and diabetic eye disease

ISRCTN	ISRCTN34037927
DOI	https://doi.org/10.1186/ISRCTN34037927
Secondary identifying numbers	08/H0808/198

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Sobha Sivaprasad
Scientific

Dept. Ophthalmology
King's College Hospital NHS Trust
Denmark Hill
London
SE5 9RS
United Kingdom

Phone	+44 (0)20 3299 3385
Email	senswathi@aol.com

Study design	Single centre randomised single blinded controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of prevention of Dark Adaptation (DA) on the progress of Diabetic Macular oEdema (DME)
Study acronym	DA and DME
Study objectives	By reducing the metabolic demand of retinal rods, which is maximal in dark adaptation, retinal hypoxia in diabetic eye disease will be reduced, and the progress of diabetic eye disease reversed.
Ethics approval(s)	Approved by Kings College Hospital Research Ethics Committee (REC) in February 2009 (ref: 08/H0808/198)
Health condition(s) or problem(s) studied	Diabetic retinopathy
Intervention	Patients will sleep wearing a device ('light mask') that illuminates one (closed) eyelid. The eye is chosen at random. The other eye acts as control. Each patient will be treated for 6 months
Intervention type	Other
Primary outcome measure	1. Ocular coherence tomography (OCT) 2. Microperimetry 3. Colour contrast sensitivity 4. Visual acuity 5. Digital fundus photography with quantitative analysis of microaneurysms Investigations are made at baseline, 3 and 6 months
Secondary outcome measures	None
Overall study start date	01/03/2009
Completion date	01/05/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Adults age 18-65 2. No systemic disease apart from diabetes (type I or II) 3. Symmetrical DME which cannot be treated surgically, or does not require immediate intervention
Key exclusion criteria	1. Any other systemic disease or severe diabetic complication 2. Any other eye condition except refractive error of > 5 D 3. History of any psychological disturbance 4. Persons of no fixed abode 5. Sleep apnoea. 6. Inability to tolerate the device, or difficulty in sleeping wearing the device.
Date of first enrolment	01/03/2009
Date of final enrolment	01/05/2010

Dept. Ophthalmology

London
SE5 9RS
United Kingdom

King's College Hospital NHS Trust (UK)
Hospital/treatment centre

Dept Ophthalmology
King's College Hospital NHS Trust
Denmark Hill
London
SE5 9RS
England
United Kingdom

Other

Internal funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No