| CTRI Number |
CTRI/2019/08/020861 [Registered on: 23/08/2019] Trial Registered Prospectively |
| Last Modified On: |
22/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The software of the new device which tests the side vision of the eye will be evaluated. |
|
Scientific Title of Study
|
Properties of perimetric threshold estimates from Full Threshold, Elisar ZEST, and Elisar Fast strategies. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrLional Raj |
| Designation |
Regional Medical director |
| Affiliation |
Dr Agarwal’s eye hospitals |
| Address |
Room No: 39
Clinical research department
3rd Floor
No.10 south Bypass Road
Vannarpettai Tirunelveli
Tirunelveli
TAMIL NADU
627003
India |
| Phone |
|
| Fax |
|
| Email |
drlionalraj@dragarwal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maheswari Srinivasan |
| Designation |
Research Manager |
| Affiliation |
Dr Agarwal’s eye hospitals |
| Address |
First floor Glaucoma department Autoperimetry room Room No :118
No 222 TTK Road Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
Details of Contact Person
Public Query
|
| Name |
Maheswari Srinivasan |
| Designation |
Research Manager |
| Affiliation |
Dr Agarwal’s eye hospitals |
| Address |
First floor Glaucoma department Autoperimetry room Room No :118
No 222 TTK Road Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
|
Source of Monetary or Material Support
|
| Dr. Agarwals eye hospitals, No.222, TTK Road, Chennai- 600018, Tamil NAdu
|
|
|
Primary Sponsor
|
| Name |
Dr Amar Agarwal |
| Address |
first floor, glaucoma department, autoperimetry room, Room no 118, no: 222, TTK road, Chennai |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Maheswari Srinivasan |
Dr. Agarwals eye hospitals Tirunelveli |
No.39,Clinical research department, 3rd floor
No.10, S Bypass Rd, Vannarpet, Vannarpettai, Tirunelveli, Tamil Nadu 627003
Tirunelveli
TAMIL NADU |
09841661134
maheswari.srinivasan@dragarwal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Agarwals eye hospital institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. The best-corrected visual acuity should be 6/6 or better.
2. Spherical equivalent of the refraction should be less than or equal to 5D |
|
| ExclusionCriteria |
| Details |
1. Fixation losses, false-positive and false-negative greater than 20% will be excluded from the study.
2. Patients using a miotic drug will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Repeatability of each strategy will also be calculated. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
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 ·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. |