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CTRI Number  CTRI/2022/08/044920 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On: 20/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Ophthalmic Surgical Knives study to assess clinical performance and safety in patients undergoing cataract surgery. 
Scientific Title of Study   Prospective, post-marketing, comparative, randomized, parallel, single blind clinical study of two Ophthalmic Surgical Knives to assess clinical performance and safety in patients undergoing 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  Prof Dr Lional Raj D 
Designation  Regional Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Dr. Agarwals Eye Hospital 10, South Bypass Road Vannarpettai Tirunelveli

Tirunelveli
TAMIL NADU
627003
India 
Phone  8754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Lional Raj D 
Designation  Regional Medical Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Dr. Agarwals Eye Hospital 10, South Bypass Road Vannarpettai Tirunelveli


TAMIL NADU
627003
India 
Phone  8754411261  
Fax    
Email  drlionalraj@dragarwal.com  
 
Details of Contact Person
Public Query  
Name  Prof A Heber 
Designation  Senior Clinical Scientist 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Dr. Agarwals Eye Hospital 10, South Bypass Road, Vannarpettai

Tirunelveli
TAMIL NADU
627003
India 
Phone  9894067910  
Fax    
Email  heber75@gmail.com  
 
Source of Monetary or Material Support  
Dr. Agarwals Eye Hospital 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr Lional Raj D   Dr. Agarwals Eye Hosptial  Dept. of Cataract & IOL Surgery No.10, South Bypass Road, Vannarpettai Tirunelveli 627003
Tirunelveli
TAMIL NADU 		 8754411261

drlionalraj@dragarwal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Agarwal’s Eye Hospital Institutional Review Board  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  Model – AA562022 - Angled Bevel up   Class B device, Polycarbonate and Stainless Steel Grade- SS 420 diameter 2.2mm 
Intervention  Model – B0762262 - Clear Cornea - Single bevel- Bevel Up  Class B device, Polycarbonate and Stainless Steel Grade- SS 420 diameter 2.2mm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age 18 year or greater
2. Cataract of any kind
3. Patient willing to participate and sign informed consent to participate in study and
to use device related data for scientific purpose
4. Patient willing to come for all post-operative follow-up
5. Female participants of child bearing potential and male participants whose partner
is of child bearing potential must be willing to ensure that they or their partner use
effective contraception during the study 
 
ExclusionCriteria 
Details  1. Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic
medications (e.g., warfarin), anti-inflammatory drugs [oral/ injectable
corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)], or other
substances known to increase coagulation time from 10 days pre- to 3 days post
injection
2. Traumatic cataract
3. Pregnancy (as stated by patient) or lactation
4. Concurrent participation in another drug or device investigation.
5. Patient receiving chloroquine treatment
6. Subjects with any systemic and metabolic disease that could increase operative risk
or confound the outcome
7. Active ocular disease in the operative eye other than cataract
8. Vulnerable subjects
9. Patient having Microphthalmia
10. Patient having chronic uveitis
11. Patient suffering from Corneal dystrophy or endothelial insufficiency
12. Patient having active ocular diseases (active diabetic retinopathy, uncontrolled
glaucoma)
13. Current participation or participation within 30 days prior to the start of this study
in a drug or other investigational research study
14. Patient who sensitive or allergic to metals 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The mean performance of both ophthalmic knives will be
evaluated by overall surgeon satisfaction score in terms of
following parameters [Time Frame: Intra-Operative]
The sharpness of blade, ease of handling the blade, smoothness of
incision creation, control while creating the wound. 		 Intra-Operative, Post-Operative
day 1 & day 30. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Wound integrity
2) Incision size accuracy
3) Astigmatism: Measurement by Pentacam. Following parameter will be measured - K1, K2 & K mean.
 		 Intra-Operative, Post-Operative
day 1 & day 30. 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   30/08/2022 
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="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Will be published in National / International Journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Through Research Publication

  6. For how long will this data be available start date provided 22-08-2022 and end date provided 22-02-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Purpose of the study is to assess clinical performance, efficacy and safety of a device
when used in accordance with its approved labelling. These may examine issues such
as medium-term performance, the appearance of clinical events, events specific to
defined patient populations, or the performance of the device in a more representative
population of providers and patients with cataract.
 
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