|
ISRCTN
|
ISRCTN66877546
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A prospective, randomised, double-masked, controlled trial of the treatment of diabetic maculopathy using diode micropulsed laser versus standard argon laser.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0013146051
|
|
Study hypothesis
|
Is the use of micropulsed diode laser application more effective than current argon laser in treatment of diabetic maculopathy?
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Eye Diseases: Macular retinopathy
|
|
Participants - inclusion criteria
|
Adults with no other ocular pathology apart from diabetic maculopathy sample all are newly diagnosed patients.
|
|
Participants - exclusion criteria
|
Patients with ocular pathology apart from diabetic maculopathy.
|
|
Anticipated start date
|
01/05/2003
|
|
Anticipated end date
|
01/05/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
50
|
|
Interventions
|
Laser application in a grid/ focal pattern to patients with macula oedema secondary to diabetic retinopathy.
|
|
Primary outcome measure(s)
|
Visual acuity, reduction of oedema by angiographic methods and use of optical coherence tomography.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
John
Shilling
|
|
Address
|
Ophthalmology
Ground Floor, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 7EH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7188 4309
|
|
Fax
|
+44
|
|
Email
|
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2005
|
|
Last edited
|
07/07/2009
|
|
Date ISRCTN assigned
|
30/09/2005
|