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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  
LENSAR 
 
Primary Sponsor  
Name  LENSAR 
Address  2800 Discovery Dr , Orlando,FL 32826,USA 
Type of Sponsor  Research institution 
 
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 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  
Status 
Not Applicable 
 
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.

 
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