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CTRI Number  CTRI/2025/11/097732 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A Study to Evaluate a New Oblique Chop Technique for Easier and Safer Cataract Surgery 
Scientific Title of Study   Oblique Chop: A Novel Hook- and -lock technique for Single Step Nuclear Fracture in Cataract Surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Om Parkash 
Designation  Cataract and Refractive Surgery Consultant 
Affiliation  Dr Om Parkash Eye Institute 
Address  117 A Mall Road
117 a the mall,Amritsar
Amritsar
PUNJAB
143001
India 
Phone  9855599959  
Fax    
Email  drrohitop@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tushya Om Parkash 
Designation  Cataract and Refractive Surgery Consultant 
Affiliation  Dr Om Parkash Eye Institute 
Address  117 A Mall Road
117 a the mall,Amritsar
Amritsar
PUNJAB
143001
India 
Phone  9980813156  
Fax    
Email  tushya@aol.in  
 
Details of Contact Person
Public Query  
Name  Tushya Om Parkash 
Designation  Cataract and Refractive Surgery Consultant 
Affiliation  Dr Om Parkash Eye Institute 
Address  117 A Mall Road
117 a the mall, Amritsar
Amritsar
PUNJAB
143001
India 
Phone  9980813156  
Fax    
Email  tushya@aol.in  
 
Source of Monetary or Material Support  
Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab, India, 143001  
 
Primary Sponsor  
Name  Rohit Om Parkash 
Address  Dr. Om Parkash Eye Institute, 117-A, The Mall, Amritsar, Punjab, India, 143001  
Type of Sponsor  Other [self funded] 
 
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 
Tushya Om Parkash  Dr Om Parkash Eye Institute  Deparment of cataract surgery,117 A, Mall Road
Amritsar
PUNJAB 		 9980813156

tushya@aol.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr Om Parkash Eye Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Oblique Chop Technique for Phacoemulsification  A novel single-pass nucleus division method employing an oblique vector approach. The chopper is introduced through the side-port incision (85°–100°) and used with both the tip and proximal arm for simultaneous anchoring and splitting of the nucleus. After initial chopping, the nucleus is rotated and oblique chops are continued until complete nuclear emulsification is achieved. A standard blunt chopper is used in all cases.The Total study duration will be 40 days. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged 40 to 80 years with visually significant cataract with grade Nuclear Sclerosis 1 to 3 as per LOCS 3 grading willing to consent. 
 
ExclusionCriteria 
Details  Pseudoexfoliation, traumatic cataracts, zonular dialysis, previous intraocular surgery, corneal or ocular pathology. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1) Single-attempt nucleus division success rate; 2) Phacoemulsification time (seconds); 3) Cumulative Dissipated Energy (CDE); 4) Capsular bag stability.  Baseline,1 month 
 
Secondary Outcome  
Outcome  TimePoints 
1) Best-Corrected Visual Acuity (BCVA); 2) Endothelial cell loss (%) at 1-month follow-up; 3) Intra- and postoperative complication rates.  Baseline, 1 month 
 
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)   30/11/2025 
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="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [drrohiitop@dromparkash.com].

  6. For how long will this data be available start date provided 01-07-2026 and end date provided 30-06-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study evaluates a new cataract surgery method called the Oblique Chop technique, designed to improve nucleus division during phacoemulsification. The technique uses a single, oblique chopping motion through the side-port incision, allowing simultaneous anchoring and splitting of the nucleus. Following the initial chop, the nucleus is rotated, and the fragments are further chopped and emulsified in a controlled manner until complete nuclear emulsification is achieved. This single-arm interventional study aims to assess the efficiency, ultrasound energy use, and safety of the technique in achieving effective nucleus division and stable intraoperative conditions. 
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