Condition category
Eye Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/09/2015
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

Mr John Shilling

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes