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Clinical Trials/CTRI/2019/05/019127
CTRI/2019/05/019127Not yet recruitingNot Applicable

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

NA4 sites in 1 country150 target enrollmentStarted: May 27, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
150
Locations
4
Primary Endpoint
The diagnostic ability of the Elisar Visual field analyser

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

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.

Outcomes

Primary Outcomes

The diagnostic ability of the Elisar Visual field analyser

Time Frame: 4 weeks

Secondary Outcomes

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

Investigators

Sponsor
NA
Sponsor Class
Other []

Study Sites (4)

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