Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013146051
Study information
Scientific title
A prospective, randomised, double-masked, controlled trial of the treatment of diabetic maculopathy using diode micropulsed laser versus standard argon laser
Acronym
Study hypothesis
Is the use of micropulsed diode laser application more effective than current argon laser in treatment of diabetic maculopathy?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Eye Diseases: Macular retinopathy
Intervention
Laser application in a grid/ focal pattern to patients with macula oedema secondary to diabetic retinopathy.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Visual acuity, reduction of oedema by angiographic methods and use of optical coherence tomography.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2003
Overall trial end date
01/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Adults with no other ocular pathology apart from diabetic maculopathy sample all are newly diagnosed patients
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
Patients with ocular pathology apart from diabetic maculopathy
Recruitment start date
01/05/2003
Recruitment end date
01/05/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St. Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St. Thomas' NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support 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