FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/01/006564 [Registered on: 27/01/2016] Trial Registered Prospectively
Last Modified On: 30/07/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Variations of intraocular pressure inside the eye during cataract surgery - Real-time measurements  
Scientific Title of Study   Realtime, Dynamic, Intraocular Pressure during microaxial phacoemulsification using the Centurion Vision System 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  Gurukul Road, Memnagar

Ahmadabad
GUJARAT
380052
India 
Phone    
Fax    
Email  icirc@abhayvasavada.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  Gurukul Road, Memnagar


GUJARAT
380052
India 
Phone    
Fax    
Email  icirc@abhayvasavada.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  Gurukul Road, Memnagar


GUJARAT
380052
India 
Phone    
Fax    
Email  icirc@abhayvasavada.com  
 
Source of Monetary or Material Support  
Alcon Laboratories Inc 6201 , South freeway ,Fort Worth , Texas 76134 
 
Primary Sponsor  
Name  Alcon Laboratories Inc 
Address  6201 , South freeway ,Fort Worth , Texas 76134 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 
Dr Abhay Vasavada  Raghudeep Eye Clinic  Drive in road branch, Mem nagar, Ahmadabad
Ahmadabad
GUJARAT 		 27490909

icirc@abhayvasavada.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Iladevi Cataract and IOL Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Cataract , (1) ICD-10 Condition: H259||Unspecified age-related cataract, (2) ICD-10 Condition: H259||Unspecified age-related cataract, (3) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Centurion Vision System  The Centurion uses Active Fluidics feedback to compensate these flow variations so that the surgical IOP is more constant in the steady state.1 2 The Centurion also has less transient variations, especially after occlusion break 1 3 The Quadrant removal settings normally utilizes the most aggressive vacuum settings and is s good step to compare system performance  
Comparator Agent  Infiniti vision system  In traditional phaco systems, surgical IOP changes with variations in aspiration flow( Infiniti) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification). Only one eye of each patient will be included 
 
ExclusionCriteria 
Details  Ocular comorbidity, glaucoma, uveitis, shallow anterior chamber, maximal pupillary dilatation 25mm), previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Surgical IOP (over the time period of the Quad portion of the surgical procedure ) measured as a peak to peak value  Surgical IOP (over the time period of the Quad portion of the surgical procedure ) measured as a peak to peak value 
 
Secondary Outcome  
Outcome  TimePoints 
Centurion Only -- Mean Surgical IOP (over the time period of the Quad portion of the surgical procedure ) – relative to IOP set point   2 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/02/2016 
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="2"
Days="5" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   To measure Realtime, Dynamic, Intraocular Pressure during microaxial phacoemulsification using the Centurion Vision System and the Infiniti vision system
Prospective, Randomized, Clinical Study: Based on a peer-reviewed method. an IOP measuring sensor will be introduced through a 1.2mm paracentesis incision during the surgery. This will be connected to an IOP transducer, then received and amplified, then converted into digital signals (via Picoscope). A video mixer will then overlay the input from the laptop and from the surgical overlay, and will allow simultaneous visualization of real-time IOP, along with the parameters being used during surgery. Likewise, this same test will be done on the Alcon Infiniti system. Mean IOP values and peak-to-peak variations will be recorded Total patients: 40 maximum  (20 per group)
 
Close