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临床试验/NCT01824862
NCT01824862已完成不适用

Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Oedema, With and Without Centre Involvement

Hospital Juarez de Mexico1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
foveal sensitivity

研究概览

简要总结

Clinically significant macular edema (CSME) is a thickening of the macula associated with the risk of visual loss, which increases its centre is involved. Functional evaluation of the macula relies on best corrected visual acuity; however, neural dysfunction in diabetic eyes appears before retinal thickening and visual loss. Retinal sensitivity decreases in eyes with CSME, but it is unknown whether it differs between eyes with and without centre thickening.

Aim: To compare the reduction of foveal sensitivity in eyes with CSME, with and without centre thickening.

详细描述

A non-experimental, comparative, prospective, cross-sectional study was conducted. Target population were type 2 diabetics, from Mexico City and its metropolitan area, and available population were type 2 diabetics who attended an Ophthalmology service from a general hospital in Mexico City, from September 2011 to May 2012.

Type 2 diabetic patients aged 30-85 years, from any gender, with central fixation, whose ocular media allowed obtaining an adequate quality Optical Coherence Tomography, who had CSME with focal angiographic pattern were included. Eyes with optic nerve or visual pathways diseases or any other ocular disease that decreased Best corrected visual acuity, were excluded. Diabetic patients without retinopathy who fulfilled the remaining selection criteria were evaluated as the reference group.

Sixty degrees colour fundus photographs were obtained in all the patients using a Visucam lite ocular fundus camera; in group 1 it was verified that no signs of diabetic retinopathy existed in the photographs; CSMO was diagnosed by biomicroscopy under mydryasis, according to the ETDRS criteria.

Retinal thickness was measured using Stratus optical coherence tomography (OCT), version 4.0.1 (Zeiss). The 6 mm fast macular map strategy was used, according to the following standardised operating procedure: mydriasis ≥6mm, inclusion of the spherical equivalent and anteroposterior axis, and optimisation of z axis and of polarisation; the photograph was taken with flash between 9:00 and 11:00, using an acquisition strategy for dark irises. The maps were obtained by the same investigator, independent from the one who evaluated the patients clinically; any deviation of the OCT line regarding the actual retina boundary was considered as a measurement error.

A 10° macular perimetry was obtained in all the patients, using a Humphrey field analyser model 750i (software version 4.1); the sixteen points evaluated were arbitrarily labelled. Retinal thickness within 3 mm from the centre of the fovea was measured in 9 fields, according to the fast macular map.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetic patients
  • aged 30-85 years
  • from any gender
  • with central fixation
  • ocular media allowed obtaining an adequate quality Optical coherence tomography
  • CSME with focal angiographic pattern

排除标准

  • optic nerve or visual pathways diseases or any other ocular disease that decreased Best corrected visual acuity

结局指标

主要结局

foveal sensitivity

时间窗: 1 day

the ability of the fovea to perceive a light stimulus in 16 central points, which is measured in dB with a 10 degree central macular perimetry

次要结局

  • Retinal thickness(1 day)

研究者

发起方
Hospital Juarez de Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Virgilio Lima Gomez

PhD

Hospital Juarez de Mexico

研究点 (1)

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