| CTRI Number |
CTRI/2021/11/037869 [Registered on: 08/11/2021] Trial Registered Prospectively |
| Last Modified On: |
23/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Portable Autorefractor- InstaRef R20 |
|
Scientific Title of Study
|
Validation of a hand-held, Portable autorefractor (InstaRef R20)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diwakar Rao |
| Designation |
HOD of Sankara College of optometry |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, 2nd floor, Sankara college of Optometry Office, Varthur Main Road, Kundalahalli Gate, Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
9972015862 |
| Fax |
|
| Email |
dot_diwakar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Diwakar Rao |
| Designation |
HOD of Sankara College of optometry |
| Affiliation |
Sankara College of optometry |
| Address |
Sankara Eye Hospital, 2nd floor, Sankara college of Optometry Office, Varthur Main Road, Kundalahalli Gate,Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
9972015862 |
| Fax |
|
| Email |
dot_diwakar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Diwakar Rao |
| Designation |
HOD of Sankara College of optometry |
| Affiliation |
Sankara College of optometry |
| Address |
Sankara Eye Hospital, 2nd floor, Sankara college of Optometry Office, Varthur Main Road, Kundalahalli Gate,Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
9972015862 |
| Fax |
|
| Email |
dot_diwakar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, 2nd floor, Sankara college of Optometry Office, Varthur Main Road, Kundalahalli Gate,Bangalore. |
|
|
Primary Sponsor
|
| Name |
Diwakar Rao |
| Address |
Sankara Eye Hospital,varthur Main Road,Kundalahalli Gate,Bangalore -560037 |
| 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 |
| Diwakar Rao |
Sankara Eye Hospital |
Sankara Eye Hospital,Ground floor Peadiatric and General Refraction room,(No:11 & 30) Varthur Main Road, Kundalahalli Gate,Bangalore.
Bangalore
KARNATAKA |
9972015862
dot_diwakar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
to assess refractive error |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with BCVA 20/20 in each eye.
Subjects with refractive errors between Sph+/-10D, Cyl +/-5D. |
|
| ExclusionCriteria |
| Details |
Subjects with significant media opacity- corneal opacity, advanced cataract, vitreous hemorrhage. posterior segment pathology affecting visual acuity, amblyopia and inability to fixate, active eye infection, inflammation. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Demonstrate the performance of InstaRef R20 when compared against subjective refraction (gold standard).
|
At the end of the study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Demonstrate the substantial equivalence in terms of performance and safety of a InstaRef R20 in measuring refractive errors when compared against a Open field AR, Plusoptic, Quicksee and standard tabletop autorefractor Topcon ARK 800.
|
At the end of the trail |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
08/11/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published , prospect of future publication . |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a Prospective Study, which is validating a Portable Autorefractor (InstaRef R20) comparing against Subjective refraction (gold standard),Open field AR, Plusoptix, Quciksee, Standard tabletop autorefractor Topcon ARK 800 and Cycloplegic refraction. This device uses a Shack Hartmann aberrometer technology, which is used to find a Refractive error,and has a distinct advantage of not only being affordable and portable but can also be used as a standalone device.
|