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CTRI Number  CTRI/2024/11/076702 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   Effectiveness of new contrast sensitivity chart in measuring contrast functions among clinical population  
Scientific Title of Study   Effectiveness of novel contrast sensitivity chart as compared to standard Pelli Robson chart in measuring contrast sensitivity in clinical practice 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namratha H 
Designation  Associate Proffessor 
Affiliation  Sankara College of Optometry 
Address  Department of Optometry, Sankara College of Optometry, Sankara Eye HOspital , Varthur Main Road , Kundalahalli Gate , Banglore

Bangalore
KARNATAKA
560037
India 
Phone  9986266576  
Fax    
Email  namratha.hedge@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Namratha H 
Designation  Associate Proffessor 
Affiliation  Sankara College of Optometry 
Address  Department of Optometry, Sankara College of Optometry, Sankara Eye HOspital , Varthur Main Road , Kundalahalli Gate , Banglore

Bangalore
KARNATAKA
560037
India 
Phone  9986266576  
Fax    
Email  namratha.hedge@gmail.com  
 
Details of Contact Person
Public Query  
Name  Namratha H 
Designation  Associate Proffessor 
Affiliation  Sankara College of Optometry 
Address  Department of Optometry, Sankara College of Optometry, Sankara Eye HOspital , Varthur Main Road , Kundalahalli Gate , Banglore

Bangalore
KARNATAKA
560037
India 
Phone  9986266576  
Fax    
Email  namratha.hedge@gmail.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital, Varthur Main Road, Kunadalahalli Signal, Bengaluru 
 
Primary Sponsor  
Name  Sankara Eye Hospital 
Address  Sankara Eye Hospital ,Varthur main road, Kundalahalli signal,Banglore 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
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 Eye Hospital  Sankara Eye Hospital,Varthur main road, Kundahalli Gate, Banglore 560037
Bangalore
KARNATAKA 		 9986266576

namratha.hedge@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: H401||Open-angle glaucoma, (3) ICD-10 Condition: H402||Primary angle-closure glaucoma, (4) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pelli Robson chart  Contrast sensitivity measured with novel chart is being compared to standard Pelli Robson contrast sensitivity chart 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  K/C/O POAG,PACG,OHT,NTG( classification based on ISGEO )
Cataract
Retinal related diseases 
 
ExclusionCriteria 
Details  Amblyopia
Pseudophakia
Corneal conditions
Secondary glaucoma
Juvenile glaucoma
Neurological conditions
Drug toxicity

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To check for the effectivness of novel contrast senstivity as comapred to standard pelli robson chart among clinical population  One visit 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the values measured with Novel Contrast Sensitivity Chart to Standard Pelli-Robson chart among clinical population  one visit 
 
Target Sample Size   Total Sample Size="176"
Sample Size from India="176" 
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)   28/11/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   An Observation study to check the effectiveness of Novel Contrast Sensitivity Chart as compared to standard Pelli-Robson chart in measuring contrast sensitivity in clinical practice, with the inclusion criteria of K/C/O POAG,PACG ,OHT and NTG(classification based on ISGEO) , cataract and retinal related conditions: Exclusion criteria of Amblyopia, pseudophakia, corneal related conditions, secondary glaucoma, juvenile glaucoma and drug toxicity. This novel chart has been created such that, it gives the contrast sensitivity at each level of visual acuity from 1.00logMAR to 0.00logMAR unlike the standard Pelli Robson CS chart with fixed letter size all throughout the chart. This novel chart may help us in identifying the subtle progression in condition among the clincial population. Hence the study aims to check the effectiveness of Novel Contrast Sensitivity Chart as compared to standard Pelli-Robson chart in measuring contrast sensitivity in clinical practice. 
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