| CTRI Number |
CTRI/2019/05/019122 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
09/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Compare screening program of Elisar and Humphrey |
|
Scientific Title of Study
|
Diagnostic Ability of a New Supra-Threshold Screening Program in Elisar Visual Field Analyzer |
| Trial Acronym |
Elisar Screening |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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
Chennai
TAMIL NADU
600018
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@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
TAMIL NADU
600018
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
TAMIL NADU
600018
India |
| Phone |
09841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
|
Source of Monetary or Material Support
|
| DrAgarwals Eye Hospital and Eye Research Centre, No-222, TTK Road, Chennai-600 018 |
|
|
Primary Sponsor
|
| Name |
Dr Amar Agarwal |
| Address |
Chairman,DrAgarwals Eye Hospital and Eye Research Centre,
Number 222,
TTK Road ,
Chennai 600018
|
| 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 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 |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| 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
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the diagnostic ability of the new Elisar Screening algorithm |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The glaucoma can be diagnosed at an early stage |
6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
20/05/2019 |
| 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
|
None 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 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. |