Condition category
Eye Diseases
Date applied
25/07/2007
Date assigned
30/08/2007
Last edited
28/09/2009
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

Dr Victor Chong

ORCID ID

Contact details

Laser and Retinal Research Unit
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
victor@eretina.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MP1

Study information

Scientific title

Acronym

Study hypothesis

Micropulse diode laser has been used for patients with clinically significant diabetic macular oedema. It has not been directly compared with the standard treatment with green laser. In this study, we are going to perform a prospective randomised double-masked controlled trial to compare these two treatment modalities.

Ethics approval

South East London Ethical Committee, approved on 14 August 2003(ref: 07-03-159)

Study design

Prospective randomised double-masked controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetic macular oedema

Intervention

Micropulse diode vs conventional green laser treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Visual acuity at 12 months.

Secondary outcome measures

The following will be assessed at 12 months:
1. Contract sensitivity
2. Central retinal thickness
3. Visible laser scars in macula

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with clinically significant macular edema due to diabetes in at least one eye
2. Able to understand and consent to the study
3. Vision acuity on study eye better than 20/200

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Ocular surgery within the past 6 months
2. Any laser surgery in the study eye
3. Any other ocular diseases in the study eye that can alter vision during the study period
4. Poor diabetic control with HBA1c >12

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Laser and Retinal Research Unit
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital (UK)

Sponsor details

Denmark Hill
London
SE5 9RS
United Kingdom
victor.chong@kch.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Ophthalmic Fund within the King's College Hospital NHS Trust (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19054831

Publication citations

  1. Results

    Figueira J, Khan J, Nunes S, Sivaprasad S, Rosa A, de Abreu JF, Cunha-Vaz JG, Chong NV, Prospective randomised controlled trial comparing sub-threshold micropulse diode laser photocoagulation and conventional green laser for clinically significant diabetic macular oedema., Br J Ophthalmol, 2009, 93, 10, 1341-1344, doi: 10.1136/bjo.2008.146712.

Additional files

Editorial Notes