| CTRI Number |
CTRI/2021/11/037900 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Exploratory |
| Study Design |
Other |
|
Public Title of Study
|
Construction & Validation of A Contrast Sensitivity Chart at Various Levels of Visual Acuity |
|
Scientific Title of Study
|
A Novel Contrast Sensitivity Chart At Various Levels Of Visual Acuity- Construction & Validation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namratha |
| Designation |
Asst.Professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Sankara College of Optometry, Department of Optometry, 2nd Floor, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore
Department of Optometry, 2nd Floor, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namratha |
| Designation |
Asst.Professor |
| Affiliation |
Sankara College of Optometry |
| Address |
Sankara College of Optometry, 2nd Floor, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore
Department of Optometry, 2nd Floor, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namratha |
| Designation |
Asst.Professor |
| Affiliation |
Sankara college of Optometry |
| Address |
Sankara College of Optometry,2nd Floor, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore
Department of Optometry, 2nd Floor, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara College of Optometry, Sankara Eye Hospital, Varthur Main Road, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Ms Namratha |
| Address |
Sankara College of Optometry, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore |
| 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 |
| Namratha |
Sankara College of Optometry |
Department of Optometry, 2nd floor, Sankara Eye Hospital, Varthur main road, Kundalahalli Signal, Bangalore
Bangalore
KARNATAKA |
9986266576
namratha.hegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ametropia & Emmetropia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
BCVA better than or equal to 0.0logMAR, N6
Emmetropes
Mild to Moderate of refractive error
Myopia - SER(-1.00 to -6.00D)
Hyperopia - SER(+1.00 to +5.00D) |
|
| ExclusionCriteria |
| Details |
With Pathological conditions
Media opacity
Active ocular infection
Amblyopia/Strabismus
Post refractive surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| New Contrast sensitivity chart with varying visual acuity |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Contrast sensitivity of normal population with novel chart |
One year |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
This is a Prospective exploratory study which aims to construct and validate a novel contrast chart with various levels of Visual Acuity. The research study will follow by two phases. First construction of the Contrast sensitivity chart primarily tested with flex print (Non tearable) material then with the acrylic material. The second phase for the validation of the chart. Selection of subjects based on Inclusion Criteria. Clinical examination will be done which includes History, Vision both distance and near, Refraction, Slit lamp examination, direct ophthalmoscopy. CS with pellirobson by co-investigator 1 then CS with new chart by co- investigator 2.Validation process will be done by Accuracy, Precision, Reportable range. Accuracy by correlation with standard and newchart, comparison by Bland Altman plot. Precision Repeatability (after 5 days) and ‘F’ test for variance. Reportable range by Highest and lowest values, For normal values. |