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ISRCTN
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ISRCTN91116795
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DOI
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10.1186/ISRCTN91116795
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Optic nerve head and ocular changes associated with micropulse diode laser in diabetic macular edema
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Scientific title
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Optic nerve head and ocular changes associated with micropulse diode laser in diabetic macular edema: a cohort study
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To determine whether the nerve fiber layer of the optic nerve head is reduced in patients with diabetic macular edema undergoing treatment with subthreshold micropulse diode laser therapy. Any thinning of the nerve fiber layer at the optic nerve head would suggest the therapy is harmful. Further, we will look at other ocular parameters in patients receiving treatment, including visual acuity and retinal thickness as measured by optical coherence tomography. Any reduction in retinal thickness or associated improvement in visual acuity would suggest the therapy is effective.
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Lay summary
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Lay summary under review 2
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Ethics approval
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University of British Columbia Rise Application System approval pending
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Study design
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Single center prospective cohort study
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Diabetic macular edema
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Participants - inclusion criteria
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1. Type I or type II diabetes mellitus
2. Clinically Significant macular edema (Confirmed by Optical Coherence Tomography)
3. HbA1 < 10.0
4. Blood Pressure < 160/100 mm Hg
5. Age > 18 years
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Participants - exclusion criteria
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1. Proliferative diabetic retinopathy
2. Retinal detachment
3. Significant media opacities
4. Previous retinal or intraocular surgery
5. Glaucoma or other ocular diseases interfering with the assessment of the results
6. Cataract extraction or lens implantation in the previous 12 months
7. Preretinal or vitreous haemorrhage
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Anticipated start date
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01/12/2012
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Anticipated end date
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01/12/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please contact bhupinder.johal@alumni.ubc.ca to request a patient information sheet
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Target number of participants
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50
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Interventions
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The standard procedure for diabetic macular edema is to
1. Go through the options available such as intraocular injections or subthreshold micropulse diode laser therapy
2. If Micropulse is chosen, go through the consent form
3. Give a date for the therapy
4. Perform a Optic Coherence Tomography Scan (OCT) of the macula
5. Perform the therapy
6. See patient after 3 months and perform another OCT scan of the macula
7. Repeat laser therapy if necessary
8. The final OCT scan of the macula
During this study, the steps would remain the same; however, when performing the OCT scan of the macula, we will also perform an OCT scan of the optic nerve head. The extra scan will take 2 minutes an eye and many studies have been published showing the safety of such a scan. Further, no radiation exposure will be administered by doing such a scan. The OCT scan of the optic nerve head is the only research related procedure that will differ from the standard care.
The extra time involved for patients required would be an extra 2 minutes for each eye affected for each visit. This would result in an additional four OCT scans and in a 6 month period, an additional 8 minutes total. The patient would not need to have any additional visits to accommodate the study and from start to finish, it would be about 6 months.
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Primary outcome measure(s)
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Optic nerve head nerve fiber layer thickness measured by optical coherence tomography measured pre-laser, 3 months and 6 months
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Secondary outcome measure(s)
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1. Visual Acuity using Snellen Visual Acuity Chart
2. Retinal Thickness using optical coherence tomography
Measured pre-laser, 3 months and 6 months
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Sources of funding
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University of Northern British Columbia (Canada) - Northern Medical Program
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Trial website
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Publications
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Contact name
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Dr
Andrew
Lukaris
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Address
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500-1488 4th Avenue
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City/town
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Prince George
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Zip/Postcode
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V2L 4Y2
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Country
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Canada
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Sponsor
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University of Northern British Columbia (Canada)
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Address
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3333 University Way
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City/town
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Prince George
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Zip/Postcode
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V2N 4Z9
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Country
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Canada
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Sponsor website:
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http://www.unbc.ca
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Date applied
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20/10/2012
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Last edited
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20/11/2012
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Date ISRCTN assigned
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20/11/2012
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