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Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

Primary Purpose

Diabetes Mellitus, Diabetic Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Optical coherence tomography angiography
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥18 Participants can have 1 or 2 study eyes

Patient Group:

  • Diabetes mellitus type 1 or 2
  • Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR

Exclusion Criteria:

  • Substantial media opacities that would preclude successful imaging

    • Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
    • Structural damage to the center of macula in the study eye
    • History of prior panretinal photocoagulation
    • History of treatment with intravitreal agents over the prior 6 months
    • Macular edema involving the central subfield
    • Prior history of vitrectomy
    • Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
    • Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
    • Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
    • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery
    • Inability to obtain fundus images of sufficient quality to be analyzed and graded

Sites / Locations

  • Eye Care CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OCTA

Arm Description

Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.

Outcomes

Primary Outcome Measures

Perfusion density
The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.

Secondary Outcome Measures

Areas of different perfusion density
Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient
Foveal avascular zone (FAZ)
Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Foveal avascular zone (FAZ)
The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Presence of predominantly peripheral lesions (PPL)
The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA
Retinal layer thickness
Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA
Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year
Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,

Full Information

First Posted
November 28, 2018
Last Updated
September 29, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03765112
Brief Title
Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
Official Title
Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.
Detailed Description
The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression. Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Retinopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCTA
Arm Type
Experimental
Arm Description
Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.
Intervention Type
Device
Intervention Name(s)
Optical coherence tomography angiography
Intervention Description
Multiple scans of the retina will be recorded to evaluate microvascular changes.
Primary Outcome Measure Information:
Title
Perfusion density
Description
The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Areas of different perfusion density
Description
Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient
Time Frame
6 months
Title
Foveal avascular zone (FAZ)
Description
Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Time Frame
6 months
Title
Foveal avascular zone (FAZ)
Description
The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Time Frame
6 months
Title
Presence of predominantly peripheral lesions (PPL)
Description
The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA
Time Frame
6 months
Title
Retinal layer thickness
Description
Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA
Time Frame
6 months
Title
Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year
Description
Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18 Participants can have 1 or 2 study eyes Patient Group: Diabetes mellitus type 1 or 2 Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR Exclusion Criteria: Substantial media opacities that would preclude successful imaging Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye Structural damage to the center of macula in the study eye History of prior panretinal photocoagulation History of treatment with intravitreal agents over the prior 6 months Macular edema involving the central subfield Prior history of vitrectomy Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery Inability to obtain fundus images of sufficient quality to be analyzed and graded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Navajas, MD
Phone
604 875 5475
Email
edunavajas@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Theresa Wiens
Phone
604-875-4111
Ext
62544
Email
twiens@eyecarecentre.org
Facility Information:
Facility Name
Eye Care Center
City
Vancouver
ZIP/Postal Code
V5Z 3N9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Navajas, MD
Phone
604 875 5475
Email
edunavajas@gmail.com
First Name & Middle Initial & Last Name & Degree
Theresa Wiens, MSc
Phone
604-875-4111
Ext
62544
Email
twiens@eyecarecentre.org
First Name & Middle Initial & Last Name & Degree
Sonja Karst, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32392316
Citation
Karst SG, Heisler M, Lo J, Schuck N, Safari A, V Sarunic M, Maberley DAL, Navajas EV. Evaluating Signs of Microangiopathy Secondary to Diabetes in Different Areas of the Retina with Swept Source OCTA. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):8. doi: 10.1167/iovs.61.5.8.
Results Reference
derived

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Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

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