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Optic nerve head and ocular changes associated with micropulse diode laser in diabetic macular edema
ISRCTN ISRCTN91116795
DOI 10.1186/ISRCTN91116795
ClinicalTrials.gov identifier
EudraCT number
Public title Optic nerve head and ocular changes associated with micropulse diode laser in diabetic macular edema
Scientific title Optic nerve head and ocular changes associated with micropulse diode laser in diabetic macular edema: a cohort study
Acronym N/A
Serial number at source N/A
Study hypothesis 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.
Lay summary Lay summary under review 2
Ethics approval University of British Columbia Rise Application System approval pending
Study design Single center prospective cohort study
Countries of recruitment Canada
Disease/condition/study domain Diabetic macular edema
Participants - inclusion criteria 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
Participants - exclusion criteria 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
Anticipated start date 01/12/2012
Anticipated end date 01/12/2013
Status of trial Completed
Patient information material Not available in web format, please contact bhupinder.johal@alumni.ubc.ca to request a patient information sheet
Target number of participants 50
Interventions 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.
Primary outcome measure(s) Optic nerve head nerve fiber layer thickness measured by optical coherence tomography measured pre-laser, 3 months and 6 months
Secondary outcome measure(s) 1. Visual Acuity using Snellen Visual Acuity Chart
2. Retinal Thickness using optical coherence tomography

Measured pre-laser, 3 months and 6 months
Sources of funding University of Northern British Columbia (Canada) - Northern Medical Program
Trial website
Publications
Contact name Dr  Andrew  Lukaris
  Address 500-1488 4th Avenue
  City/town Prince George
  Zip/Postcode V2L 4Y2
  Country Canada
Sponsor University of Northern British Columbia (Canada)
  Address 3333 University Way
  City/town Prince George
  Zip/Postcode V2N 4Z9
  Country Canada
  Sponsor website: http://www.unbc.ca
Date applied 20/10/2012
Last edited 20/11/2012
Date ISRCTN assigned 20/11/2012
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