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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04808804
Enrollment
80
Registered
2021-03-22
Start date
2021-06-30
Completion date
2022-06-30
Last updated
2021-03-23

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

Conditions

Neurodegeneration, Retinal Neuropathy

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTOptical Coherence Tomography (OCT)

a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
RNFL thicknessBaselineretinal nerve fiber layer (RNFL) will be evaluated

Contacts

Primary ContactEmel Saad Tawadrous, MBBCh
emelsaad@ymail.com+201284854021

Outcome results

None listed

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