The software of the new device which tests the side vision of the eye will be evaluated.

Not yet recruiting

• Conditions: Unspecified glaucoma,

• Registration Number: CTRI/2019/08/020861
• Lead Sponsor: Dr Amar Agarwal

Brief Summary

Introduction: Elisar’s Visual field Analyser is a portable device that can be used to perform perimetry. The stimulus intensity starts with the value obtained from a normal population. From the patient’s response, a new curve is obtained. The probability curve obtained from the normative data and the patient’s response will give a new probability curve

Methods:

Twenty healthy volunteers and fifty glaucoma patients will be recruited from the Dr. Agarwal’s eye hospitals, Tirunelveli.

Trial Sequence:1.     Full threshold strategy( 4 times), Elisar zest ( 4 times), Elisar fast ( 4 times),Elisar screening. (2 times).

Analysis:

Variability will be measured as a function of Â·Age, Sensitivity  , Eccentricity, Diagnosis( glaucoma/ normal), The rate of false negative,The rate of fixation loss,The rate of false positive.Single estimate of each strategy (Elisar ZEST, Elisar FAST) will be compared with the mean of three full threshold examinations. This will avoid the statistical artifact that will arise due to the regression to the mean effect.Sensitivity and specificity of the screening test will be calculated against the result of full threshold test’s Glaucoma Hemi field Test (GHT) as normal or outside the normal limits.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-08-22
• Study Start: 2019-08-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• The best-corrected visual acuity should be 6/6 or better.
• Spherical equivalent of the refraction should be less than or equal to 5D.

Exclusion Criteria

• Fixation losses, false-positive and false-negative greater than 20% will be excluded from the study.
• Patients using a miotic drug will be excluded from the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This will evaluate the Full threshold, Elisar Zest, Elisar fast and Elisar Screening. This will give a knowledge on how accurate the above strategies are.	90 days

Secondary Outcome Measures

Name	Time	Method
Repeatability of each strategy will also be calculated.	90 days

Trial Locations

Locations (1)

Dr. Agarwals eye hospitals Tirunelveli; 🇮🇳 Tirunelveli, TAMIL NADU, India

Dr. Agarwals eye hospitals Tirunelveli

🇮🇳Tirunelveli, TAMIL NADU, India

Maheswari Srinivasan

Principal investigator

09841661134

maheswari.srinivasan@dragarwal.com