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

NCT04808804 | Unknown

• 1 other identifier: Neurodegeneration In DM
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Retinal Neuropathy; Neurodegeneration

Outcome Measures

Primary Outcomes (1)

• RNFL thickness

  retinal nerve fiber layer (RNFL) will be evaluated

  Baseline

Study Arms (2)

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)

Healthy

healthy controls

Diagnostic Test: Optical Coherence Tomography (OCT)

Interventions

Optical Coherence Tomography (OCT) DIAGNOSTIC_TEST

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

DM; Healthy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, Garcia-Arumi J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simao S, Schwartz C, Ponsati B, Porta M, Costa MA, Hernandez C, Cunha-Vaz J, Simo R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.

  PMID: 28663190 BACKGROUND

• Shahidi AM, Sampson GP, Pritchard N, Edwards K, Vagenas D, Russell AW, Malik RA, Efron N. Retinal nerve fibre layer thinning associated with diabetic peripheral neuropathy. Diabet Med. 2012 Jul;29(7):e106-11. doi: 10.1111/j.1464-5491.2012.03588.x.

  PMID: 22269030 BACKGROUND

• Salvi L, Plateroti P, Balducci S, Bollanti L, Conti FG, Vitale M, Recupero SM, Enrici MM, Fenicia V, Pugliese G. Abnormalities of retinal ganglion cell complex at optical coherence tomography in patients with type 2 diabetes: a sign of diabetic polyneuropathy, not retinopathy. J Diabetes Complications. 2016 Apr;30(3):469-76. doi: 10.1016/j.jdiacomp.2015.12.025. Epub 2015 Dec 30.

  PMID: 26809902 BACKGROUND

• Simo R, Hernandez C; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Neurodegeneration in the diabetic eye: new insights and therapeutic perspectives. Trends Endocrinol Metab. 2014 Jan;25(1):23-33. doi: 10.1016/j.tem.2013.09.005. Epub 2013 Nov 1.

  PMID: 24183659 BACKGROUND

• Zangwill LM, Bowd C. Retinal nerve fiber layer analysis in the diagnosis of glaucoma. Curr Opin Ophthalmol. 2006 Apr;17(2):120-31. doi: 10.1097/01.icu.0000193079.55240.18.

  PMID: 16552246 BACKGROUND

• Petzold A, de Boer JF, Schippling S, Vermersch P, Kardon R, Green A, Calabresi PA, Polman C. Optical coherence tomography in multiple sclerosis: a systematic review and meta-analysis. Lancet Neurol. 2010 Sep;9(9):921-32. doi: 10.1016/S1474-4422(10)70168-X.

  PMID: 20723847 BACKGROUND

• Satue M, Garcia-Martin E, Fuertes I, Otin S, Alarcia R, Herrero R, Bambo MP, Pablo LE, Fernandez FJ. Use of Fourier-domain OCT to detect retinal nerve fiber layer degeneration in Parkinson's disease patients. Eye (Lond). 2013 Apr;27(4):507-14. doi: 10.1038/eye.2013.4. Epub 2013 Feb 22.

  PMID: 23429414 BACKGROUND

• Marziani E, Pomati S, Ramolfo P, Cigada M, Giani A, Mariani C, Staurenghi G. Evaluation of retinal nerve fiber layer and ganglion cell layer thickness in Alzheimer's disease using spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Sep 5;54(9):5953-8. doi: 10.1167/iovs.13-12046.

  PMID: 23920375 BACKGROUND

• Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.

  PMID: 2866759 BACKGROUND

• van Dijk HW, Verbraak FD, Stehouwer M, Kok PH, Garvin MK, Sonka M, DeVries JH, Schlingemann RO, Abramoff MD. Association of visual function and ganglion cell layer thickness in patients with diabetes mellitus type 1 and no or minimal diabetic retinopathy. Vision Res. 2011 Jan 28;51(2):224-8. doi: 10.1016/j.visres.2010.08.024. Epub 2010 Aug 27.

  PMID: 20801146 BACKGROUND

• Fischer MD, Huber G, Beck SC, Tanimoto N, Muehlfriedel R, Fahl E, Grimm C, Wenzel A, Reme CE, van de Pavert SA, Wijnholds J, Pacal M, Bremner R, Seeliger MW. Noninvasive, in vivo assessment of mouse retinal structure using optical coherence tomography. PLoS One. 2009 Oct 19;4(10):e7507. doi: 10.1371/journal.pone.0007507.

  PMID: 19838301 BACKGROUND

• Ceklic L, Maar N, Neubauer AS. Optical coherence tomography fast versus regular macular thickness mapping in diabetic retinopathy. Ophthalmic Res. 2008;40(5):235-40. doi: 10.1159/000127830. Epub 2008 Apr 25.

  PMID: 18437033 BACKGROUND

• Wilkinson CP, Ferris FL 3rd, Klein RE, Lee PP, Agardh CD, Davis M, Dills D, Kampik A, Pararajasegaram R, Verdaguer JT; Global Diabetic Retinopathy Project Group. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology. 2003 Sep;110(9):1677-82. doi: 10.1016/S0161-6420(03)00475-5.

  PMID: 13129861 BACKGROUND

MeSH Terms

Conditions

Nerve Degeneration

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Central Study Contacts

Emel Saad Tawadrous, MBBCh

CONTACT

+201284854021; emelsaad@ymail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-03