| CTRI Number |
CTRI/2019/05/019106 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
15/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
To compare new perimeter Elisars algorithm called Zest with SITA standard algorithm |
|
Scientific Title of Study
|
Comparison of the New Elisar Zest Algorithm with Swedish Interactive Thresholding Algorithm |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| 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
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
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-19, Cathedral Road, Gopalapuram, Chennai-600 086 |
|
|
Primary Sponsor
|
| Name |
Dr Amar Agarwal |
| Address |
Chairman,DrAgarwals Eye Hospital and Eye Research Centre, No-19,Cathedral 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 Agarwal s Eye hospitals |
First floor, Glaucoma department, Autoperimetry room, Room No :118
No 222 , TTK Road, Chennai
Chennai
TAMIL NADU |
044-43008800
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 |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1.The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years.
2.Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm)
3.IOP <21 mmHg (intraocular difference less than 3 mmHg).
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Fixation losses, false positive and false negative > 20% 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 a correlation between Elisar and Humphrey visual field analyzer. If both the devices correlate well, Elisar can be used in place of Humphrey due its portable nature. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glaucoma can be picked up at the early stage due to its affordability and portable nature. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/06/2019 |
| 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="0"
Days="30" |
|
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
|
Protocol Summary The purpose of our study is to compare the threshold values of Elisar Visual Field Analyzer with Humphrey Visual Field Analyzer. Study design: Cross-sectional study. Inclusion criteria: 1. The best corrected visual acuity should be 6/6 for age <55 years and 6/9 or better for age >55 years. 2. Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm) ◠IOP <21 mmHg (intraocular difference less than 3 mmHg). Exclusion criteria: 1. Fixation losses, false positive and false negative > 20% will be excluded from the study. Methodology: 1. A comprehensive ophthalmological examination will be performed which includes detailed ocular and medical history, visual acuity, intraocular pressure (IOP), Vertical cup-disc ratio assessment with OCT 2. Only one eye of a subject will be taken for the study. 3. Elisar zest 30-2 and Humphrey’s SITA standard will be done. Analysis: The threshold values from Elisar zest 30-2 will be compared with the Humphrey Field Analyzer’s SITA standard 30-2 using sectors wise correlation coefficients. The mean sensitivity values of both the devices will be taken to plot the Bland Altman plots. |