| CTRI Number |
CTRI/2020/04/024647 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
comparison of the new device Elisar AVA s updated algorithm and it current algorithm |
|
Scientific Title of Study
|
Comparison of threshold estimates of current version Elisar 30-2 full threshold algorithm with the updated version of Elisar 30-2 full threshold algorithm and with 30-2 full threshold algorithm of Humphrey 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 |
Maheswari Srinivasan |
| Designation |
Manager , Clinical sciences |
| Affiliation |
Dr. Agarwals eye hospitals |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
No.50, G2 C block, Sudharshan flats, Big Street, Zameen Royapet, Chromepet
Chennai
TAMIL NADU
600006.
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maheswari Srinivasan |
| Designation |
Manager , Clinical sciences |
| Affiliation |
Dr. Agarwals eye hospitals |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
No.50, G2 C block, Sudharshan flats, Big Street, Zameen Royapet, Chromepet
Chennai
TAMIL NADU
600006.
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
Details of Contact Person
Public Query
|
| Name |
Maheswari Srinivasan |
| Designation |
Manager , Clinical sciences |
| Affiliation |
Dr. Agarwals eye hospitals |
| Address |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
No.50, G2 C block, Sudharshan flats, Big Street, Zameen Royapet, Chromepet
Chennai
TAMIL NADU
600006.
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 = 4 |
| 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 |
| Maheswari Srinivasan |
Dr Agarwal s Eye hospitals, Tambaram |
No 6 TDK Towers Duraiswamy Reddy Street West Tambaram Chennai 600045
Chennai
TAMIL NADU |
09841661134
maheswari.srinivasan@dragarwal.com |
| Maheswari Srinivasan |
Dr Agarwal s Eye hospitals,Anna Nagar |
No 31 F Block 2nd Avenue Anna Nagar East Chennai-600102
Chennai
TAMIL NADU |
09841661134
maheswari.srinivasan@dragarwal.com |
| Maheswari Srinivasan |
Dr. Agarwals eye hospitals, Porur |
TVS Arasu Motors No 118 Arcot Rd Opposite to Ganesh Nagar Porur Chennai Tamil Nadu 600116
Chennai
TAMIL NADU |
09841661134
maheswari.srinivasan@dragarwal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Dr Agarwals eye hospital institutional review board |
Approved |
| Dr Agarwals eye hospital institutional review board |
Approved |
| Dr Agarwals eye hospital institutional review board |
Approved |
| 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
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Abnormal subjects consist of both Glaucoma and other conditions with decibel values of less than 9 dB in HFA will be included in the study
For controls:
2.The best-corrected visual acuity of 6/12 or better as measured with Snellen’s visual acuity char
|
|
| ExclusionCriteria |
| Details |
1. Patients who had undergone ocular surgeries (other than cataract surgery), patients with ocular disease, amblyopia, neurological disorders will be excluded from the study.
2. Patients using a miotic drug will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the equivalence between threshold estimates of updated algorithm of 30-2 Elisar AVA and the 30-2 of Humphrey visual field analyser |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the equivalence between threshold estimates of updated algorithm of 30-2 Elisar AVA and the 30-2 of Humphrey visual field analyser |
45 days |
|
|
Target Sample Size
|
Total Sample Size="109"
Sample Size from India="109"
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)
|
27/04/2020 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: The aim of our study is to compare the threshold
estimates of the current version of Elisar full threshold 30-2 with the updated version of full threshold 30-2 of Elisar AVATM and with
full threshold 30-2 of Humphrey visual field analyzer.
field
analyzer in both a healthy group and a study group exhibiting advanced
field loss (with threshold values less than 9 dB).
Methods: A comprehensive initial screening should be
done to confirm whether the patient met the inclusion/exclusion criteria. Those
patients who meet the inclusion criteria will undergo trial procedures by
following the randomization sheet. Analysis: Bland Altman plots and Intraclass correlation will be done to compare the results from both the devices.
|