| CTRI Number |
CTRI/2019/08/020609 [Registered on: 07/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
New device Elisar Visual field analyzer collects data on normal population. |
|
Scientific Title of Study
|
Developing Normative Database for Elisar Visual Field Analyzer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vamsi Chintalapati |
| Designation |
Scientist |
| Affiliation |
Dr. Agarwals eye hospitals |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
Chennai
TAMIL NADU
600018
India |
| Phone |
044-43008800 |
| Fax |
|
| Email |
vamsi.c@dragarwal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maheswari Srinivasan |
| Designation |
Research Manager |
| Affiliation |
Dr. Agarwals eye hospitals |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
Kancheepuram
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. Agarwals eye hospitals |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
Kancheepuram
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 Agarwals eye hospitals |
| Address |
222, TTK Road
Alwarpet
Chennai 600018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Agarwal s Eye hospitals |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
Chennai
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 |
| Healthy Human Volunteers |
Normal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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 equivalent of the correction should be less than or equal to +/- 5 D
3.Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm)
4.IOP <21 mmHg ( intraocular difference less than 3 mmHg).
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Data that is required for running the algorithm of the visual field analyser |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The other subjects will be compared with this data and they can be categorised as normal or abnormal . |
60 days |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/08/2019 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of our study is to
develop the database of normal subjects by testing 74 points using 30-2 full threshold
algorithm of EVFA in phase 1, 68 points using 10-2 full threshold algorithm in
phase II and 16 points using macular threshold in phase III of the clinical
trial.
Description of study device:
Elisar
Visual Field Analyzer (EVFA) is the Virtual Reality (VR) based perimeter with
full threshold algorithm which measures up to 30 degrees of the visual field
with eye tracking.
Study duration: 2 months.
Expected commencement date: 20 th
August 2019
The expected completion date of the
project: 20 th October 2019.
Study design: A Cross sectional study. The proposed method of statistical
analysis:
The linear model for age effects
will be constructed for each of the locations of the 30°field. The age
slopes and the intercepts will be derived for each of the locations and fovea.
|