FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/01/048676 [Registered on: 02/01/2023] Trial Registered Prospectively
Last Modified On: 02/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of vision following intraocular lens implantation using two different machines. 
Scientific Title of Study   Comparison of postoperative outcomes following Toric IOL implantation using an image guided versus a femto laser enabled capsular marking system for intraoperative IOL positioning. 
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  CHIEF MEDICAL DIRECTOR 
Affiliation  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256/14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU

Bangalore
KARNATAKA
560070
India 
Phone  9845129740  
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHEETAL BRAR 
Designation  FELLOWSHIP DIRECTOR 
Affiliation  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256/14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU

Bangalore
KARNATAKA
560070
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR SHUBHANGI SHEVALE 
Designation  FELLOW 
Affiliation  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL 
Address  2ND FLOOR, OPD BLOCK, PHACO REFRACTIVE DEPARTMENT, NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256/14, KANAKAPURA ROAD, OPP. ICICI BANK, 7TH BLOCK, JAYANAGAR, BENGALURU

Bangalore
KARNATAKA
560070
India 
Phone  9987602209  
Fax    
Email  shubhangishevale91@gmail.com  
 
Source of Monetary or Material Support  
LENSAR Inc. 2800 Discovery Drive Orlando, FL 32826 888-536-7271 
 
Primary Sponsor  
Name  LENSAR 
Address  LENSAR INC 2800 DISCOVERY DRIVE ORLANDO, FL 32826 888-536-7271 
Type of Sponsor  Other [OPHTHALMIC COMPANY] 
 
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 SHUBHANGI SHEVALE  NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL  Phacorefractive Department, 2nd Floor, New OPD Block, 256/14 Kanakpura Main Road, Opposite ICICI Bank, 7th Block Jayanagar, Bengaluru, 560070 Bangalore KARNATAKA Bangalore KARNATAKA Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9987602209

shubhangishevale91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics committee for research on human subjects,Nethradhama superspeciality 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PHACOEMULSIFICATION CATARACT SURGERY WITH TORIC IOL IMPLANTATION DONE USING AN IMAGE GUIDED SYSTEM (CALLISTO)  PHACOEMULSIFICATION CATARACT SURGERY WITH TORIC IOL IMPLANTATION DONE USING AN IMAGE GUIDED SYSTEM (CALLISTO)FOR INTRAOPERATIVE TORIC IOL POSITIONING. FREQUENCY - 1 TIME. DURATION - 15 MINS FOR ONE EYE 
Intervention  PHACOEMULSIFICATION CATARACT SURGERY WITH TORIC IOL IMPLANTATION DONE USING FEMTOLASER ENABLED CAPSULAR MARKING SYSTEM (INTELLIAXIS)   PHACOEMULSIFICATION CATARACT SURGERY WITH TORIC IOL IMPLANTATION DONE USING FEMTOLASER ENABLED CAPSULAR MARKING SYSTEM (INTELLIAXIS) FOR INTRAOPERATIVE TORIC IOL POSITIONING. FREQUENCY OF INTERVENTION- 1 TIME. DURATION OF INTERVENTION- 15 MINS FOR ONE EYE. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  − Healthy eyes besides age related cataract, aged between 40-80 years
− Eyes undergoing femtolaser assisted surgery with implantation of a hydrophobic monofocal toric IOL
− Regular corneal topography and corneal astigmatism within the range of 0.75D to 4.00D
− Availability, willingness, and sufficient cognitive awareness to
comply with examination procedures
− Signed informed consent 
 
ExclusionCriteria 
Details  − Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation, and corneal endothelial cell insufficiency.
− Subjects with any systemic disease that could increase operative risk or confound the outcome
− Pregnant or lactating or planning a pregnancy at the time of enrolment
− Any patient who is taking part in another study involving ocular
surgery
− Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under Mesopic/scotopic conditions)
− Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
− Post-op residual cylinder (D)
− Manifest refraction (Sphere, Cylinder, Spherical Equivalent)
− Uncorrected Distance Visual Acuity (UDVA) and Corrected Distance
Visual Acuity (CDVA) using ETDRS charts at 4m
− Rotational stability using dilated clinical examination and I-trace
(Tracey technologies, Hoya, Japan).
 		 1 WEEK, 1 MONTH, 3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1.Precision (Success/ Failure) of intra-operative image capture
2.Intra-operative adverse events /post-op rotation/ re-surgery rate 		 Intraoperative  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/01/2023 
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   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

It would be a matter of great interest to study and compare two different types of registration systems, i.e., limbal (IOL Master 700 and Callisto eye) and iris registration (LENSAR laser system and Intelliaxis) for precision of image capturing, and accuracy of cylinder correction following toric IOL implantation. The present study would thus be conducted to compare both the systems in terms of success and precision of intra-operative image capture as well as outcomes of astigmatism correction following implantation of a toric IOL implant. 

 
Close