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临床试验/CTRI/2019/05/019127
CTRI/2019/05/019127尚未招募不适用

Glaucoma diagnostic ability of Elisar Visual field Analyzer in comparison with Optical Coherence Tomography

NA4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
4
主要终点
The diagnostic ability of the Elisar Visual field analyser

研究概览

简要总结

Dr. Agarwal’s Eye Hospital Institutional Review Board

Chennai – 600018

PROJECT SUMMARY

Introduction: Glaucoma, is a leading cause of irreversible blindness in the world.1 Early disease detection and treatment are important for the prevention of visual impairment 2.

Elisar’s new mobile visual field analyzer is a portable device that can be used to perform perimetry.

Studies have shown that structural changes in glaucoma primarily affect retinal ganglion cells (RGC) and their axons.3

Several studies have demonstrated that Cirrus HD OCT  can measure GCIPL thickness with excellent reproducibility in both normal and glaucomatous subjects.4

Objective: To establish the diagnostic ability of the Mobile Perimeter using the OCT results in Glaucoma.

Study Design:  Case-control study trial.

Methodology: The patients who are diagnosed to have Glaucoma will be divided into Early Glaucomatous and Advanced Glaucomatous patient group . Both the group of patients will undergo Humphrey and Elisar visual field analyser and OCT imaging examination.The reports of both group of patients will be compared based on their parameters.

Sample Size: 75 eyes of normal subjects, 75 eyes of glaucomatous subjects.

Inclusion Criteria: Patients with age > 18 years, best corrected visual acuity of 20/40 or better and refractive error within + 5 Diopters (D) sphere and + 3 D cylinder.

Exclusion Criteria: Presence of any media opacities or Any retinal or neurologic disease.

Expected Outcome: The Parameters of Humphrey with OCT and Elisar mobile visual field analyser with OCT is similar for detecting Early Glaucoma.

Duration: 3 Months

Dr. Dhivya Ashok Kumar

Chief investigator

REFERENCE:

  1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90:262– 267

  2. Jeoung JW, Choi YJ, Park KH, Kim DM. Macular ganglion cell imaging study: glaucoma diagnostic accuracy of spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013;54(7):4422–9. pmid:23722389.

  3. Medeiros FA, Lisboa R, Weinreb RN, Liebmann JM, Girkin C, Zangwill LM. Retinal ganglion cell count estimates associated with early development of visual field defects in glaucoma. Ophthalmology. 2013;120(4):736–44.

  4. Mwanza JC, Oakley JD, Budenz DL, Chang RT, Knight OJ, Feuer WJ. Macular ganglion cell-inner plexiform layer: automated detection and thickness reproducibility with spectral domain-optical coherence tomography in glaucoma. Invest Ophthalmol Vis Sci. 2011;52(11):83239.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Patients with age > 18 years, best corrected visual acuity of 20/40 or better and refractive error within + 5 Diopters (D) sphere and + 3 D cylinder.

排除标准

  • •Presence of any media opacities or Any retinal or neurologic disease.

结局指标

主要结局

The diagnostic ability of the Elisar Visual field analyser

时间窗: 4 weeks

次要结局

  • The comparison of Elisar visual field analyser and the OCT(3 months)

研究者

发起方
NA
申办方类型
Other []

研究点 (4)

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