Retinal Neurodegeneration In Type 2 Diabetes Mellitus Detected by Optical Coherence Tomography

March 19, 2021 updated by: Emel Saad Tawadrous, Assiut University

Retinal Neurodegeneration In Patients With Type 2 Diabetes Mellitus Without Diabetic Retinopathy or With Mild Non Proliferative Diabetic Retinopathy Detected by Optical Coherence Tomography

Evaluation of retinal neurodegeneration in patients with type 2 diabetes mellitus (DM2) without diabetic retinopathy or with mild non proliferative diabetic retinopathy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Retinal complications in diabetes mellitus (DM) patients were typically considered part of a vascular process. However, recent studies suggest that ocular degeneration in DM might be caused by 2 different conditions: vasculopathy and neuropathy . For some authors, neuropathy observed in the retina of DM patients might be a part of an underlying polyneuropathy ; for others, however, neuropathic changes might precede microvascular alterations .

Axons of retinal ganglion cells compose the retinal nerve fiber layer (RNFL) in the retina and then form the optic nerve connecting the eyeball and brain. Retinal nerve fiber layer (RNFL) loss is recognized as an important neurodegenerative sign in glaucoma. Thinning of the RNFL has also been found in multiple sclerosis, Parkinson's disease and Alzheimer's disease, indicating neurodegeneration of the retina. If RNFL thinning is significant in diabetic patients with preclinical diabetic retinopathy, evaluation of peripapillary RNFL thickness would be very important, because early detection and treatment of diabetic retinopathy is critical to reduce the risk of blindness Optical coherence tomography (OCT) has been introduced into clinical practice as the most noninvasive and objective method to visualize the retina, showing an amount of detail that resembles histological specimens. Initially, OCT was applied to detect complications of DR (edema macular or epiretinal membrane). Later on, it allowed quantitative and qualitative measurements of retinal thickness and segmentation of all intraretinal layers. OCT might detect early retinal neurodegenerative changes, and thus help define which diabetic patients may be at risk to develop DR.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 eyes of patients with DM2 and without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy and 40 eyes of healthy controls

Description

Inclusion Criteria:

  • All patients with confirmed type 2 DM diagnosis of at least 6 months
  • Best-corrected visual acuity (BCVA) of 6/12 or higher (using a Snellen chart) in each eye
  • Intraocular pressure (by applanation) less than 21 mmHg.
  • Healthy controls had no record nor evidence of ocular or neurologic disease of any kind; their BCVA is > 6/9 based on the Snellen scale.

Exclusion Criteria:

  • presence or past history of moderate or severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy , confirmed by indirect funduscopy or retinography images.
  • presence of significant refractive errors (≥5 diopters of spherical equivalent refraction or 3 diopters of astigmatism)
  • intraocular pressure ≥21 mmHg
  • media opacifications
  • concomitant ocular diseases, including history of glaucoma or retinal pathology
  • systemic conditions that could affect the visual system, including neurodegenerative disorders such as Parkinson's disease, multiple sclerosis, or dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DM
Patients With Type 2 Diabetes Mellitus without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy
Diagnostic test: Optical Coherence Tomography (OCT)
a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
Healthy
healthy controls
Diagnostic test: Optical Coherence Tomography (OCT)
a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNFL thickness
Time Frame: Baseline
retinal nerve fiber layer (RNFL) will be evaluated
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurodegeneration In DM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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