| CTRI Number |
CTRI/2019/05/019091 [Registered on: 13/05/2019] 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
|
Perimetry with neutral density filter |
|
Scientific Title of Study
|
Measuring the perimetric threshold in reduced retinal illumination using Elisar and Humphrey visual field Analyzer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDhivya Ashok Kumar |
| Designation |
Research Head adn consultant Ophthalmologist |
| 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 |
susruta2002@gmail.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
600044
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
Chennai
TAMIL NADU
600044
India |
| Phone |
9841661134 |
| Fax |
|
| Email |
maheswari.srinivasan@dragarwal.com |
|
|
Source of Monetary or Material Support
|
| Dr. Agarwals eye hospitals |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
9841661134
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 |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20-25 years
Cycloplegic refractive errors,+0.75 to -2.25D of Spherical error and < -0.50D of astigmatic error.
|
|
| ExclusionCriteria |
| Details |
Presence of any media opacities
Any retinal (including macular) or neurological diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The perimetric threshold in reduced retinal illumination |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of amount of drop in sensitivity with Elisar visual field analyzer and Humphrey visual field Analyzer |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="7"
Sample Size from India="7"
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)
|
27/05/2019 |
| 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="3"
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
|
Dr. Agarwal’s Eye Hospital Institutional Review Board
Chennai – 600018
PROJECT SUMMARY
Introduction: Glaucoma is the second leading cause of blindness in the world, affecting more than 60 million people globally.1 The differential light threshold is influenced by factors, such as the subject’s age, alertness, media clarity, ocular diseases, ocular medications, and systemic medications.2 Early Glaucomatous field loss will have a diffuse pattern in perimetry report.3 Elisar Visual Field Analyser is a portable device which can detect early glaucoma and can reduce the number of people affected with severe field loss. By introducing Neutral Density Filter (NDF) and reducing the retinal illumination to understand the visual field loss in glaucomatous patients.
Objective: To measure the perimetric threshold in reduced retinal Illumination using Elisar and Humphrey Visual Field Analyser.
Study Design: Cross-sectional experimental study trial.
Methodology: All subjects will be performing 4 Elisar Visual Field Analyser examination and 4 Humphrey Visual Field Analyser examination with a series of Neutral Density Filter placed in front of the right eye. The subject will undergo Dilation process by instilling eye drop and closing the eye for 45 minutes. After the dilation, if the subject’s pupil,30 minutes of dark adaptation is given before the examination. After each examination, tropicamide will be instilled to maintain the dilation and also 30 minutes of dark adaptation.
Sample Size: 7 Normal Subjects
Inclusion Criteria: Patients with age between 20–46 years, cycloplegic refractive errors,+0.75 to -2.25D of Spherical error and < -0.50D of astigmatic error.
Exclusion criteria: Patient with the presence of any media opacities or neurological diseases.
Expected Outcome: The ability of Elisar Visual Field Analyser to detect early glaucomatous visual field loss is similar to Humphrey Visual Field Analyser.
Duration: 2 months
Ethical Consideration: Waiting for Approval.
Reference:
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020.Br J Ophthalmol.2006;90:262–7.
Heuer, D. K., Anderson, D. R., Feuer, W. J., Knighton, R. W., Gressel, M. G., and Fantes, F. E.: The influence of simulated media opacities on threshold measurements. In Greve, E. L., and Heijl, A. (eds.): Proceedings of the 7th International Visual Field Symposium. Dordrecht, The Netherlands, Martinus Nijhoff/Dr. W. Junk Publishers, 1987, pp. 15-22.
Diffuse Loss of Sensitivity in Early Glaucoma
David B.Henson; Paul H.Artes; Balwantray C.Chauhan.
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