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CTRI Number  CTRI/2021/09/036289 [Registered on: 07/09/2021] Trial Registered Prospectively
Last Modified On: 15/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To check the agreement of measurement of the difference in the luminance and brightness of a target using two different software, namely Freiburg Visual Acuity and Contrast Test and quick Contrast Sensitivity Function  
Scientific Title of Study   Agreement of measurement of contrast sensitivity and its function using Freiburg Visual Acuity and Contrast Test and quick Contrast Sensitivity Function 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jivitha J 
Designation  Post Graduate Student  
Affiliation  Manipal College of Health Professions 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9551160712  
Fax    
Email  jivitha.j@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Avik Ray  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9538529218  
Fax    
Email  avik.ray@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Jivitha J 
Designation  Post Graduate Student  
Affiliation  Manipal College of Health Professions 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104, Karnataka
Udupi
KARNATAKA
576104
India 
Phone  9551160712  
Fax    
Email  jivitha.j@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Jivitha J 
Address  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104, Karnataka, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jivitha J   Vision Science Lab  Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA 		 9551160712

jivitha.j@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  There should be no history of any previously diagnosed ocular conditions or contrast sensitivity deficits.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  • Subjects with best corrected visual acuity 6/6 or better.
• Subjects who can read and understand the English language.
• No history of any previously diagnosed ocular conditions. 
 
ExclusionCriteria 
Details  • Subjects with low vision
• Subjects above the age limit of 40 years.
• Subjects who cannot read and understand the English language.
• Subjects already known to have contrast sensitivity deficits.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Contrast sensitivity in log units and Contrast sensitivity function curve.
 		 Baseline and 1 week.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2021 
Date of Study Completion (India) 14/04/2022 
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  

Contrast sensitivity plays a vital role in the assessment of visual function and the need for psychometric measurement has found its importance in optometry. Earlier, visual acuity charts like Pelli-Robson and Mars charts were used which only detects the generalized defects and was used predominantly in out-patient procedure because it was easy, and less time is required. But one of the disadvantages was the lack of ability to detect frequency-based deficits. There are many works of literature based on the comparison of various contrast sensitivity charts but there is a lack of evidence to check the test-retest variability and agreement between Freiburg Visual Acuity and Contrast Test [FrACT] and quick Contrast Sensitivity Function [qCSF] which also measures the contrast threshold using psychophysical technique.The aim of the study is to check the agreement and stability of measurements taken at different time points using Freiburg Visual Acuity and Contrast Test and quick contrast sensitivity function. And to determine the limits of agreement and check the test-retest variability of Freiburg Visual acuity and Contrast Test and quick Contrast Sensitivity Function. 

 
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