Glaucoma diagnostic ability of Elisar Visual field Analyzer in comparison with Optical Coherence Tomography
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:
-
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90:262– 267
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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.
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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.
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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)
