A prospective, randomised, double-masked, controlled trial of the treatment of diabetic maculopathy using diode micropulsed laser versus standard argon laser

ISRCTN ISRCTN66877546
DOI https://doi.org/10.1186/ISRCTN66877546
Secondary identifying numbers N0013146051
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
01/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr John Shilling
Scientific

Ophthalmology
Ground Floor, South Wing (Block 7)
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA prospective, randomised, double-masked, controlled trial of the treatment of diabetic maculopathy using diode micropulsed laser versus standard argon laser
Study objectivesIs the use of micropulsed diode laser application more effective than current argon laser in treatment of diabetic maculopathy?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEye Diseases: Macular retinopathy
InterventionLaser application in a grid/ focal pattern to patients with macula oedema secondary to diabetic retinopathy.
Intervention typeProcedure/Surgery
Primary outcome measureVisual acuity, reduction of oedema by angiographic methods and use of optical coherence tomography.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2003
Completion date01/05/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteriaAdults with no other ocular pathology apart from diabetic maculopathy sample all are newly diagnosed patients
Key exclusion criteriaPatients with ocular pathology apart from diabetic maculopathy
Date of first enrolment01/05/2003
Date of final enrolment01/05/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St. Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust

No information available

Own account

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan