Micropulse diode vs conventional green laser treatment in clinically significant diabetic macular oedema

ISRCTN	ISRCTN90646644
DOI	https://doi.org/10.1186/ISRCTN90646644
Protocol serial number	MP1
Sponsor	King's College Hospital (UK)
Funder	Ophthalmic Fund within the King's College Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Victor Chong
Scientific

Laser and Retinal Research Unit
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Email	victor@eretina.org

Primary study design	Interventional
Study design	Prospective randomised double-masked controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	South East London Ethical Committee, approved on 14 August 2003(ref: 07-03-159)
Health condition(s) or problem(s) studied	Diabetic macular oedema
Intervention	Micropulse diode vs conventional green laser treatment
Intervention type	Other
Primary outcome measure(s)	Visual acuity at 12 months.
Key secondary outcome measure(s)	The following will be assessed at 12 months: 1. Contract sensitivity 2. Central retinal thickness 3. Visible laser scars in macula
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2007

Laser and Retinal Research Unit

London
SE5 9RS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009		Yes	No