Skip to content

Diabetic Retinopathy and Subclinical Signs of Disease Transition

Diabetic Retinopathy and Subclinical Signs of Disease Transition

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03635671
Acronym
DIRECTION
Enrollment
5
Registered
2018-08-17
Start date
2018-09-01
Completion date
2019-07-15
Last updated
2019-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Imaging, Diabetes, OCTA

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.

Interventions

DIAGNOSTIC_TESTOptical Coherence Tomography Angiography

Retinal scans will be acquired at each follow up visit

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perfusion density6 monthsMean change of perfusion density of the macula evaluated within the 9 ETDRS subfields for the superior and inferior vascular plexus separately.

Secondary

MeasureTime frameDescription
Perfusion density12 monthsMean change of perfusion density of the macula evaluated within the 9 ETDRS subfields for the superior and inferior vascular plexus separately.
Retinal layer thickness6 and 12 monthsMean change in retinal layer thickness of all retinal layers separately

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026