Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2023-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Diabetic Retinopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OCTA

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

Group Type EXPERIMENTAL

Optical coherence tomography angiography

Intervention Type DEVICE

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

Interventions

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Optical coherence tomography angiography

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes