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
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Emel Saad Tawadrous, MBBCh
- 电话号码:+201284854021
- 邮箱:emelsaad@ymail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:其他
- 时间观点:横截面
队列和干预
团体/队列 |
干预/治疗 |
---|---|
DM
Patients With Type 2 Diabetes Mellitus without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy
|
a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
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Healthy
healthy controls
|
a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
RNFL thickness
大体时间:Baseline
|
retinal nerve fiber layer (RNFL) will be evaluated
|
Baseline
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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