| CTRI Number |
CTRI/2019/08/020796 [Registered on: 20/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A new diagnostic algorithm SITA FASTER for glaucoma with a shorter testing time - is it accurate and precise as the gold standard algorithm SITA STANDARD? |
|
Scientific Title of Study
|
Newer Algorithm SITA (Swedish Interactive Threshold Algorithm) Faster - Is it better? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maj Gen Mrs Sagarika Patyal |
| Designation |
Senior Consultant |
| Affiliation |
Centre for sight eye institute |
| Address |
Exam Room No.3
First floor
Department of Glaucoma
Centre for sight eye institute
Plot-9, Sector-9
Dwarka
New Delhi
South West
DELHI
110075
India |
| Phone |
9643437024 |
| Fax |
|
| Email |
sagarikapatyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maj Gen Mrs Sagarika Patyal |
| Designation |
Senior Consultant |
| Affiliation |
Centre for sight eye institute |
| Address |
Exam Room No.3
First floor
Department of Glaucoma
Centre for sight eye institute
Plot-9, Sector-9
Dwarka
New Delhi
South West
DELHI
110075
India |
| Phone |
9643437024 |
| Fax |
|
| Email |
sagarikapatyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mithun Thulasidas |
| Designation |
Fellow |
| Affiliation |
Centre for sight eye institute |
| Address |
Exam Room No.8
First floor
Department of Comprehensive Ophthalmology
Centre for sight eye institute
Plot-9, Sector-9
Dwarka
New Delhi
South West
DELHI
110075
India |
| Phone |
7406298745 |
| Fax |
|
| Email |
mithun.thulasidas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Centre for sight eye institute |
| Address |
Centre for sight eye institute
Plot - 9, Sector - 9
Dwarka
New Delhi - 110075 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Mithun Thulasidas |
Centre for sight eye institute |
Exam Room No.3
First floor
Department of Glaucoma
Centre for sight eye institute
Plot-9, Sector-9
Dwarka
New Delhi
South West
DELHI |
7406298745
mithun.thulasidas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre For Sight Institutional Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Glaucoma suspect and Primary open angle glaucoma |
|
| ExclusionCriteria |
| Details |
Secondary Glaucoma, Retinopathy /Neurological comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Deviation
Pattern Standard Deviation
Visual field index
Foveal threshold |
Single visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Test time
Test points |
After test |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2019 |
| Date of Study Completion (India) |
28/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PURPOSE
To compare HFA 24‑2 SITA Faster, SITA Fast (SF) and SITA Standard (SS)
visual field programs in glaucoma patients.
METHOD
This is a cross‑sectional observational study involving 70 eyes of glaucoma suspect and primary open angle patients. Outcomes included Mean Deviation, Pattern Standard Deviation, Visual Field Index, foveal threshold, test time
and significant test points in probability maps. |