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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000369325
Ethics application status
Approved
Date submitted
15/07/2008
Date registered
30/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Micropulse laser treatment study
Scientific title
In patients with Diabetic Maculopathy, is micropulse laser treatment, better than argon laser treatment, at improving or stabilising visual acuity and reducing retinal oedema?
Secondary ID [1] 640 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Maculopathy 3413 0
Condition category
Condition code
Eye 3597 3597 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 3598 3598 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Micropulse laser, single treatment, via slit-lamp microscope.
One eye with condition to be treated.
The radiant exposure of the laser will be 70 - 120mJ/cm2 per treatment spot.
Treatment duration 10 to 30 minutes.
Overall intervention period will be 1yr.
Intervention code [1] 3141 0
Treatment: Devices
Comparator / control treatment
Argon laser, single treatment, via slit-lamp microscope.
Treatment duration 10 to 30 minutes.
The radiant exposure of the laser will be 16 - 250J/cm2 per treatment spot.
Control group
Active

Outcomes
Primary outcome [1] 4467 0
Improvement or stabilisation of visual acuity
Timepoint [1] 4467 0
Baseline testing pre treatment, with 3 and 6 month follow-up testing
Secondary outcome [1] 7538 0
Reduction in retinal oedema measured by OCT (Optical Coherance Tomography) retinal thickness.
Timepoint [1] 7538 0
Baseline testing pre treatment, with follow-up testing at 3 and 6 months.

Eligibility
Key inclusion criteria
Type 2 diabetes
Focal or diffuse macular oedema
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous laser treatment
Proliferative retinopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by shuffling of envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3599 0
Commercial sector/Industry
Name [1] 3599 0
Ellex R&D Pty Ltd
Address [1] 3599 0
82 Gilbert Street, Adelaide, South Australia, 5000
Country [1] 3599 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ellex R&D Pty Ltd
Address
82 Gilbert Street, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 3235 0
None
Name [1] 3235 0
Address [1] 3235 0
Country [1] 3235 0
Other collaborator category [1] 334 0
Hospital
Name [1] 334 0
Royal Adelaide Hospital
Address [1] 334 0
1 North Terrace, Adelaide, South Australia, 5000
Country [1] 334 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5686 0
Research Ethics Committee, Royal Adelaide Hospital
Ethics committee address [1] 5686 0
Level 3, Hanson Institute, 1 North Terrace, Adelaide, South Australia, 5000
Ethics committee country [1] 5686 0
Australia
Date submitted for ethics approval [1] 5686 0
Approval date [1] 5686 0
18/03/2008
Ethics approval number [1] 5686 0
071123a

Summary
Brief summary
The primary purpose of the study is to determine if in patients with Diabetic Maculopathy micropulse laser treatment is better than argon laser treatment, at improving or stabilising visual acuity and reducing retinal oedema.
The hypothesis is that the micropulse laser may provide as good or better therapeutic benefit as compared to current treatments but without the damage normally associated with this treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28753 0
Address 28753 0
Country 28753 0
Phone 28753 0
Fax 28753 0
Email 28753 0
Contact person for public queries
Name 11910 0
malcolm plunkett
Address 11910 0
82 Gilbert Street, Adelaide, South Australia, 5000
Country 11910 0
Australia
Phone 11910 0
08 81045200
Fax 11910 0
Email 11910 0
mplunkett@ellex.com
Contact person for scientific queries
Name 2838 0
malcolm plunkett
Address 2838 0
82 Gilbert Street, Adelaide, South Australia, 5000
Country 2838 0
Australia
Phone 2838 0
08 81045200
Fax 2838 0
Email 2838 0
mplunkett@ellex.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary