| CTRI Number |
CTRI/2019/05/019204 [Registered on: 20/05/2019] Trial Registered Prospectively |
| Last Modified On: |
16/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Compare visual fields with New Elisar perimeter device with Humphrey perimeter with new software algorithm |
|
Scientific Title of Study
|
Comparison of the New Elisar Fast Algorithm with Swedish Interactive thresholding Algorithm fast |
| 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 |
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 |
9841661134 |
| 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 |
9841661134 |
| 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 |
9841661134 |
| 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] |
|
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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- 600018
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 |
|
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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 |
Controls:
1.Cup disc ratio less than 0.5 (intraocular difference of 0.2 mm)
2.IOP <21 mmHg (intraocular difference less than 3 mmHg)(10).
3.The normal result of Glaucoma Hemifield test in HFA 30-2 SITA fast
Glaucoma and non-glaucomatous field loss:
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 a cup-disc ratio less than more than 0.2.
2.A positive report of the SITA standard with Humphrey visual field analyzer.
3. The best corrected visual acuity should be better than or equal to 6/12.
4. Spherical correction should be < 5 D, Cylindrical correction should be < 3 D.
|
|
| ExclusionCriteria |
| Details |
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. The lid artifact is defined as the density of the defect greater than or equal to 11 decibels (dB) for a single test location or greater than or equal to 7 dB for two adjacent test locations according to the pattern deviation from age-corrected normal values. Second, the defect must involve loci between 20° and 30°.
3. Patients who had undergone ocular surgeries (other than cataract surgery), patients with ocular disease, amblyopia, neurological disorders will be excluded from the study.
4. Patients using a miotic drug will be excluded from the study.
|
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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 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. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glaucoma can be picked up at an early stage due to its affordability and portable nature. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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="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
|
Protocol Summary The purpose of our study is to compare the Elisar Visual Field Analyzer with Humphrey Visual Field Analyzer. Description of the study device Elisar Visual Field Analyzer (EVFA) is the Virtual Reality (VR) based perimeter which measures up to 30 degrees of the visual field with eye tracking. Study duration: 15 days. Study design: A 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) ◠3.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 fast 30-2 and Humphrey’s SITA fast will be done. Analysis: The threshold values from Elisar fast 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. |