Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Lukaris

ORCID ID

Contact details

500-1488 4th Avenue
Prince George
V2L 4Y2
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Optic nerve head and ocular changes associated with micropulse diode laser in diabetic macular edema: a cohort study

Acronym

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.

Ethics approval

University of British Columbia Rise Application System approval pending

Study design

Single center prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact bhupinder.johal@alumni.ubc.ca to request a patient information sheet

Condition

Diabetic macular edema

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Optic nerve head nerve fiber layer thickness measured by optical coherence tomography measured pre-laser, 3 months and 6 months

Secondary outcome measures

1. Visual Acuity using Snellen Visual Acuity Chart
2. Retinal Thickness using optical coherence tomography

Measured pre-laser, 3 months and 6 months

Overall trial start date

01/12/2012

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/12/2012

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Canada

Trial participating centre

500-1488 4th Avenue
Prince George
V2L 4Y2
Canada

Sponsor information

Organisation

University of Northern British Columbia (Canada)

Sponsor details

3333 University Way
Prince George
V2N 4Z9
Canada

Sponsor type

University/education

Website

http://www.unbc.ca

Funders

Funder type

University/education

Funder name

University of Northern British Columbia (Canada) - Northern Medical Program

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

Publication citations

Editorial Notes