Diabetic Retinopathy and Subclinical Signs of Disease Transition

NCT ID: NCT03635671

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-07-15

Brief Summary

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. Some factors are known to temporarily aggravate or improve diabetic retinopathy, but underlying pathophysiologic factors are still unknown. High-resolution imaging techniques of the retina and its supplying vascular networks now allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In detail, the investigators image study patients with optical coherence tomography (OCT) - technology, that provides morphological information of retinal structure and the supplying vessels in a non-invasive way. Retinal layer thickness as well as capillary density will be quantified and followed in patients that are in a critical period of disease transition to better understand the process of diabetic retinopathy.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intensified blood glucose control

Patients with diabetes mellitus type 2 and poor blood sugar control that are introduced to insulin or GLP-1 therapy

Optical Coherence Tomography Angiography

Intervention Type: DIAGNOSTIC_TEST

Retinal scans will be acquired at each follow up visit

Nephropathy

Patients that are introduced to hemodialysis or renal transplantation secondary to renal failure

Optical Coherence Tomography Angiography

Intervention Type: DIAGNOSTIC_TEST

Retinal scans will be acquired at each follow up visit

Interventions

Optical Coherence Tomography Angiography

Retinal scans will be acquired at each follow up visit

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Optical Coherence Tomography

Eligibility Criteria

Inclusion Criteria

• Diabetes mellitus type 1 or 2
• Age 18-90

Exclusion Criteria

• Media opacities like cataract or vitreous hemorrhage
• 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
• Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
• Ocular disorders 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 photographs or fluorescein angiograms of sufficient quality to be analyzed and graded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

David Maberley

MD, FRCSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Maberley, MD

Role: PRINCIPAL_INVESTIGATOR

Head of the Department of Ophthalmology and Visual Science, UBC

Locations

Eye Care Center

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

DIRECTION

Identifier Type: -

Identifier Source: org_study_id