| CTRI Number |
CTRI/2019/05/019127 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
13/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Diagnose glaucoma with new Elisar mobile perimeter |
|
Scientific Title of Study
|
Glaucoma diagnostic ability of Elisar Visual field Analyzer in comparison with Optical Coherence Tomography |
| Trial Acronym |
OCT study |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDhivya Ashok Kumar |
| Designation |
Research Head and 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
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
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 |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
9841661134
maheswari.srinivasan@dragarwal.com |
| Maheswari Srinivasan |
Dr Agarwal s Eye hospitals, Tambaram |
Autoperimetry, Ground floor, Glaucoma department, No, 6, TDK tower, Durai swamy reddy street, Tambaram west, Chennai 600045
Chennai
TAMIL NADU |
09841661134
maheswari.srinivasan@dragarwal.com |
| Maheswari Srinivasan |
Dr Agarwal s Eye hospitals,Anna Nagar |
First floor, Autoperimetry, Glaucoma department,
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 |
Autoperimetry room, Glaucoma department, no.118, Arcot road, Porur, Chennai- 600116
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 |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age > 18 years, best corrected visual acuity of 20/40 or better and refractive error within + 5 Diopters (D) sphere and + 3 D cylinder.
|
|
| ExclusionCriteria |
| Details |
Presence of any media opacities or Any retinal or neurologic disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The diagnostic ability of the Elisar Visual field analyser |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The comparison of Elisar visual field analyser and the OCT |
3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 a leading cause of irreversible blindness in the world.1 Early disease detection and treatment are important for the prevention of visual impairment 2. Elisar’s new mobile visual field analyzer is a portable device that can be used to perform perimetry. Studies have shown that structural changes in glaucoma primarily affect retinal ganglion cells (RGC) and their axons.3 Several studies have demonstrated that Cirrus HD OCT can measure GCIPL thickness with excellent reproducibility in both normal and glaucomatous subjects.4
Objective: To establish the diagnostic ability of the Mobile Perimeter using the OCT results in Glaucoma.
Study Design: Case-control study trial.
Methodology: The patients who are diagnosed to have Glaucoma will be divided into Early Glaucomatous and Advanced Glaucomatous patient group . Both the group of patients will undergo Humphrey and Elisar visual field analyser and OCT imaging examination.The reports of both group of patients will be compared based on their parameters.
Sample Size: 75 eyes of normal subjects, 75 eyes of glaucomatous subjects.
Inclusion Criteria: Patients with age > 18 years, best corrected visual acuity of 20/40 or better and refractive error within + 5 Diopters (D) sphere and + 3 D cylinder.
Exclusion Criteria: Presence of any media opacities or Any retinal or neurologic disease.
Expected Outcome: The Parameters of Humphrey with OCT and Elisar mobile visual field analyser with OCT is similar for detecting Early Glaucoma.
Duration: 3 Months
Dr. Dhivya Ashok Kumar Chief investigator
REFERENCE:
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90:262– 267
Jeoung JW, Choi YJ, Park KH, Kim DM. Macular ganglion cell imaging study: glaucoma diagnostic accuracy of spectral-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2013;54(7):4422–9. pmid:23722389.
Medeiros FA, Lisboa R, Weinreb RN, Liebmann JM, Girkin C, Zangwill LM. Retinal ganglion cell count estimates associated with early development of visual field defects in glaucoma. Ophthalmology. 2013;120(4):736–44.
Mwanza JC, Oakley JD, Budenz DL, Chang RT, Knight OJ, Feuer WJ. Macular ganglion cell-inner plexiform layer: automated detection and thickness reproducibility with spectral domain-optical coherence tomography in glaucoma. Invest Ophthalmol Vis Sci. 2011;52(11):83239.
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