Contact information
Type
Scientific
Primary contact
Miss Sobha Sivaprasad
ORCID ID
Contact details
Dept. Ophthalmology
King's College Hospital NHS Trust
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 3385
senswathi@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
08/H0808/198
Study information
Scientific title
The effect of prevention of Dark Adaptation (DA) on the progress of Diabetic Macular oEdema (DME)
Acronym
DA and DME
Study hypothesis
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
Approved by Kings College Hospital Research Ethics Committee (REC) in February 2009 (ref: 08/H0808/198)
Study design
Single centre randomised single blinded controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/2009
Overall trial end date
01/05/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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.
Recruitment start date
01/03/2009
Recruitment end date
01/05/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept. Ophthalmology
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
King's College Hospital NHS Trust (UK)
Sponsor details
Dept Ophthalmology
King's College Hospital NHS Trust
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)2073599080
geoffreyarden@aol.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22020171
Publication citations
-
Results
Arden GB, Jyothi S, Hogg CH, Lee YF, Sivaprasad S, Regression of early diabetic macular oedema is associated with prevention of dark adaptation., Eye (Lond), 2011, 25, 12, 1546-1554, doi: 10.1038/eye.2011.264.