| CTRI Number  | 
    CTRI/2021/12/038418 [Registered on: 03/12/2021] Trial Registered Prospectively | 
    | Last Modified On: | 
    19/11/2021 | 
	
    | Post Graduate Thesis  | 
    No  | 
    | Type of Trial  | 
    Interventional  | 
    | 
    Type of Study
       
           | 
    Medical Device  | 
    | Study Design  | 
    Single Arm Study  | 
    | 
    Public Title of Study
                
                        
           
     
      | 
    
TO EVALUATE THE SAFETY EFFICIENCY AND PREDICTABILITY OF THE  INCISIONS CREATED ON THE CORNEA BY THE FEMTOSECOND LASER (LENSAR) ASSISTED CATARACT SURGERY TO CORRECT PREOPERATIVE CORNEAL ASTIGMATISM AT THE TIME OF CATARACT SURGERY
  | 
    | 
    Scientific Title of Study
                 
                        
           
           | 
    TO EVALUATE THE SAFETY , EFFICACY AND PREDICTABILITY OF FEMTOSECOND LASER (LENSAR) ENABLED ARCUATE INCISIONS FOR THE CORRECTION OF PREOPERATIVE TOPOGRAPHIC ASTIGMATISM AT THE TIME OF CATARACT SURGERY  | 
    | Trial Acronym  | 
      | 
    | 
    Secondary IDs if Any
                 
                        
           
           | 
    
    
    
        | Secondary ID  | 
        Identifier  | 
     
            
            | NIL  | 
            NIL  | 
         
     
     
  | 
    | 
    Details of Principal Investigator or overall Trial Coordinator (multi-center study)
                 
                        
           
           | 
    
        
        
            | Name  | 
            Dr Sri Ganesh    | 
         
	
            | Designation  | 
            	Chairman Managing Director    | 
         
	
            | Affiliation  | 
            NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL  | 
         
	
        
            | Address  | 
            Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA
Bangalore
KARNATAKA
560082
India 
  Bangalore KARNATAKA 560082 India  | 
                 
        
            | Phone  | 
               | 
                 
        
            | Fax  | 
               | 
                 
        
            | Email  | 
            phacomaverick@gmail.com   | 
                         
         
      | 
    
    Details of Contact Person Scientific Query
                 
                        
           
           | 
    
        
        
            | Name  | 
            DR SHEETAL BRAR  | 
         
	
            | Designation  | 
            SENIOR CONSULATANT AND RESEARCH DIRECTOR  | 
         
	
            | Affiliation  | 
            NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL  | 
         
        
            | Address  | 
            Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA
Bangalore
KARNATAKA
560082
India 
  Bangalore KARNATAKA 560082 India  | 
                 
        
            | Phone  | 
               | 
                 
        
            | Fax  | 
               | 
                 
        
            | Email  | 
            brar_sheetal@yahoo.co.in   | 
                         
         
      | 
    
    Details of Contact Person Public Query
                  
                        
           
           | 
    
        
        
            | Name  | 
            DR SAHITI SALGUTI  | 
         
		
            | Designation  | 
            FELLOW PHACOREFRACTIVE  | 
         
	
            | Affiliation  | 
            NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL  | 
         
        
            | Address  | 
            Nethradhama Superspeciality Eye Hospital 256/14, kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA
Bangalore
KARNATAKA
560082
India 
  Bangalore KARNATAKA 560082 India  | 
                 
        
            | Phone  | 
               | 
                 
        
            | Fax  | 
               | 
                 
        
            | Email  | 
            salgutisahiti@gmail.com   | 
                         
         
      | 
    | 
    Source of Monetary or Material Support
                  
                        
           
           | 
    
    
     
  | 
    | 
    Primary Sponsor
                  
                        
           
           | 
    
        
        
            | Name  | 
            LENSAR  | 
                     
        
            | Address  | 
            2800 Discovery Dr , Orlando,FL 32826,USA  | 
         
        
            | Type of Sponsor  | 
                        Research institution  | 
         
         
      | 
    | 
    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  | 
     
    	
        
        | DR SHEETAL BRAR  | 
        Nethradhama Superspeciality Eye Hospital   | 
        Nethradhama Superspeciality Eye Hospital
PHACOREFRACTIVE DEPARTMENT 2ND BUILDING  
256/14, kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA
Bangalore
KARNATAKA
560082
India  Bangalore KARNATAKA  | 
        9591002092
  brar_sheetal@yahoo.co.in  | 
     
                
         
      | 
    | 
    Details of Ethics Committee
                  
                        
           
           | 
    
        
    
           | No of Ethics Committees= 1   | 
     
           
                | Name of Committee  | 
                Approval Status  | 
               
             
            
                | NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL  | 
                Approved  | 
              
                     
         
      | 
    | 
    Regulatory Clearance Status from DCGI
                  
                        
           
           | 
        
        
      | 
    | 
    Health Condition / Problems Studied
                  
                        
           
           | 
    
        
            
                | Health Type  | 
                Condition  | 
             
		
    		| Healthy Human Volunteers  | 
    		cataract  | 
  		 
	
         
      | 
    | 
    Intervention / Comparator Agent
                  
                        
           
           | 
    
        
            
                | Type  | 
                Name  | 
                Details  | 
             
  
    | Intervention  | 
    LENSAR FEMTOSECOND ENABLED ARCUATE INCISION  | 
    ARCUATE INCISION CREATED BY LENSAR FEMTOSECOND LASER DEVICE TO CORRECT TOPOGRAPHIC ASTIGMATISM AT THE TIME OF CATARACT SURGERY FOR ONE YEAR  | 
   
    
    | Comparator Agent  | 
    NA  | 
    NA  | 
   
           
      | 
    | 
    Inclusion Criteria
                  
                        
           
                | 
    
        
            
                | Age From  | 
                40.00 Year(s) | 
             
            
                | Age To  | 
                75.00 Year(s) | 
             
                        
                | Gender  | 
                Both  | 
                    
            
                | Details  | 
                CATARACT EYES WITH NO COMORBIDITIES  
ASTIGMATISM OF -0.75D TO -2D 
UNILATERAL EYE  | 
                  
         
      | 
    | ExclusionCriteria  | 
    
        
	            
            
                               
            
                | Details  | 
                CORNEAL ECTATIC CONDITIONS 
CORNEAL SCARS 
PTERYGIUM 
POST REFRACTIVE SURGERY 
GLAUCOMA 
RETINAL PATHOLOGIES  | 
                  
         
      | 
    | 
    Method of Generating Random Sequence
                  
                        
           
           | 
    Not Applicable  | 
    | 
    Method of Concealment
                  
                        
           
           | 
    Not Applicable  | 
    | 
    Blinding/Masking
                  
                        
           
           | 
    Not Applicable  | 
    | 
    Primary Outcome
                  
                        
           
           | 
    
        
             
                | Outcome  | 
                TimePoints  |                 
             
            
                | TO EVALUATE THE EFFICACY SAFETY AND PREDICTABILITY  OF ARCUATE INCISIONS TO CORRECT CORNEAL ASTIGMATISM CREATED BY THE LENSAR FEMTOSECOND LASER DEVICE   | 
                PREOP , POSTOP-1DAY,3MONTHS , 12 MONTHS   | 
             
         
      | 
    | 
    Secondary Outcome
                  
                        
           
           | 
    
        
             
                | Outcome  | 
                TimePoints  |                 
             
                
                | TO EVALUATE REGRESSION OF ASTIGMATISM IN THE NEXT 12 MONTHS FOLLOW UP PERIOD  | 
                PREOP , POSTOP-1DAY,3MONTHS , 12 MONTHS  | 
             
         
      | 
    | 
    Target Sample Size
                  
                        
           
           | 
    Total Sample Size="100" Sample Size from India="100"   
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)
                  
                        
           
           | 
    16/12/2021  | 
	
| 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 Yet Recruiting  | 
    | Recruitment Status of Trial (India)  | 
    Not Yet Recruiting  | 
    | 
    Publication Details
                     
                        
           
           | 
    
    
    
    
    
    NIL  | 
	
| 
     Individual Participant Data (IPD) Sharing Statement
 | 
	
      
    
        Will individual participant data (IPD) be shared publicly (including data dictionaries)?   
                   Response - NO           
         
   
 | 
    | 
    Brief Summary
                  
                        
           
           | 
    Phacoemulsification is the gold standard for cataract surgery. With constant improvements and continuous upgradations, most of the modern phacoemulsification systems on the market have improved on safety and efficacy, leading to reduced surgical times and lower rates of intra-operative complications, translating into better postoperative outcomes and patient satisfaction. Surgical efficiency, however, may vary, depending upon the surgeon’s skills as well as the machine settings. A good clinical outcome depends on the combination of both. In line with these advancements, a new femtosecond laser system “LENSAR†has been recently updated to correct the topographic pre-operative astigmatism by arcuate incisions. The system has a unique ability to mark the arcuate incision on the cornea with the inbuilt woodcock nomogram, the reference image can directly be transferred to the LENSAR from the Pentacam, or if old versions of Pentacam are used it can also be transferred through an external hard disk, the device also has a unique ability to auto correct the cyclorotation by iris identification software after the patient is in supine position to maximize the results.   |