Condition category
Eye Diseases
Date applied
30/10/2009
Date assigned
30/11/2009
Last edited
11/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes