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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Emel Saad Tawadrous, MBBCh
- Telefoonnummer: +201284854021
- E-mail: emelsaad@ymail.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Ander
- Tijdsperspectieven: Dwarsdoorsnede
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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DM
Patients With Type 2 Diabetes Mellitus without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy
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a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
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Healthy
healthy controls
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a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
RNFL thickness
Tijdsspanne: Baseline
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retinal nerve fiber layer (RNFL) will be evaluated
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Baseline
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Lancet Neurol. 2010 Nov;9(11):1045.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Meer informatie
Termen gerelateerd aan deze studie
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Andere studie-ID-nummers
- Neurodegeneration In DM
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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