Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT03765112

Conditions

Diabetes Mellitus

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Optical coherence tomography angiography

Study Details

Brief summary:

This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.

Conditions

Diabetes Mellitus

Diabetic Retinopathy

Study ID

NCT03765112

Start date

Sep 20, 2018

Status verified date

Sep, 2021

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

175 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: OCTA

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

Interventions

Optical coherence tomography angiography

Multiple scans of the retina will be recorded to evaluate microvascular changes.

Primary outcome measure

  • Perfusion density [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Eduardo Navajas, MD

604 875 5475edunavajas@gmail.com

Theresa Wiens

604-875-4111twiens@eyecarecentre.org

Locations

Eye Care Center

Recruiting

Vancouver, Canada, V5Z 3N9

Contacts

Eduardo Navajas, MD

604 875 5475edunavajas@gmail.com

Theresa Wiens, MSc

604-875-4111twiens@eyecarecentre.org

More Information

Sponsor

University of British Columbia

Last update posted

Oct 1, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2021-10-01.