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Clinical Trials/CTRI/2019/05/019122
CTRI/2019/05/019122Not yet recruitingNot Applicable

Diagnostic Ability of a New Supra-Threshold Screening Program in Elisar Visual Field Analyzer

Dr Amar Agarwal1 site in 1 country160 target enrollmentStarted: May 20, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
To establish the diagnostic ability of the new Elisar Screening algorithm

Study Overview

Brief Summary

Protocol Summary:

The purpose of our study is to compare the Elisar Supra threshold algorithm with the Humphrey‘s screening algorithm.

Description of study device:

Elisar Visual Field Analyzer (EVFA) is the Virtual Reality (VR) based perimeter.

Study design: A cross sectional study.

Inclusion criteria:

Controls:

1.   The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.

2.   Spherical correction should be < 5 D, Cylindrical correction should be < 3 D.

Glaucoma:

 1.     Glaucoma is defined as IOP greater than 21 mmHg or intraocular difference in IOP more than 3mmHg and Cup disc ratio more than 0.5, and the intraocular difference in cup disc ratio less than more than 0.2.

2.     A positive report of the screening test with Humphrey visual field analyzer.

Exclusion criteria:

1.   Fixation losses , false positive and false negative > 20% will be excluded from the study.

2.   The reports with significant lid artifact will be excluded from the study.

Study Design

Study Type
Observational

Eligibility Criteria

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

Inclusion Criteria

  • •Controls: 1.The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.
  • •2.Spherical correction should be < 5 D, Cylindrical correction should be < 3 D.
  • •Glaucoma: Glaucoma is defined as the IOP greater than 21 mmHg or intraocular difference in IOP more than 3mmHg and Cup disc ratio more than 0.5, and the intraocular difference in cup disc ratio less than more than 0.2.

Exclusion Criteria

  • •Patients who had undergone ocular surgeries (other than cataract surgery), patients with ocular disease, amblyopia, neurological disorders will be excluded from the study.
  • •Patients using a miotic drug will be excluded from the study.

Outcomes

Primary Outcomes

To establish the diagnostic ability of the new Elisar Screening algorithm

Time Frame: 45 days

Secondary Outcomes

  • The glaucoma can be diagnosed at an early stage(6 months)

Investigators

Sponsor
Dr Amar Agarwal
Sponsor Class
Other [self]

Study Sites (1)

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