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CTRI Number  CTRI/2025/08/093070 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARING TWO METHODS TO IMPROVE VISION AFTER CATARACT SURGERY IN SMALL EYES : TRADITIONAL VS AI BASED KANE FORMULA 
Scientific Title of Study   VISUAL AND REFRACTIVE OUTCOME OF INTRAOCULAR LENS CALCULATION IN SHORT EYES: HOFFER-Q VERSUS AI BASED KANE FORMULA A COMAPARATIVE STUDY : RANDOMISED CONTROL TRIAL 
Trial Acronym  VISION SAFE Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Padarthi 
Designation  Ophthalmology resident 
Affiliation  mahatma gandhi medical college and research institute 
Address  MGMCRI, Department of ophthalmology,Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry 607402

Pondicherry
PONDICHERRY
607402
India 
Phone  7396859070  
Fax    
Email  priyankapadarthi279@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. K. Srikanth 
Designation  Ophthalmology resident 
Affiliation  mahatma gandhi medical college and research institute 
Address  MGMCRI,Department of Ophthalmology,Pondicherry - Cuddalore Rd,ECR, Pillayarkuppam,Puducherry 607402
MGMCRI,Department of Ophthalmology,Pondicherry - Cuddalore Rd,ECR, Pillayarkuppam,Puducherry 607402
Pondicherry
PONDICHERRY
607402
India 
Phone  7396859070  
Fax  9443332240  
Email  kskanth99@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka Padarthi 
Designation  Ophthalmology resident 
Affiliation  mahatma gandhi medical college and research institute 
Address  MGMCRI,Department of Ophthalmology, Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry 607402
MGMCRI,Department of Ophthalmology, Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY
607402
India 
Phone  7396859070  
Fax    
Email  priyankapadarthi279@gmail.com  
 
Source of Monetary or Material Support  
NO MONEY INVOLVEMENT MGMCRI Department of Ophthalmology 
 
Primary Sponsor  
Name  PriyankaPadarthi 
Address  MGMCRI,Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry 607402 
Type of Sponsor  Private medical college 
 
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 
DRPRIYANKA PADARTHI  Mahatma Gandhi Medical College  Department of ophthalmology,Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry 607403
Pondicherry
PONDICHERRY 		 7396859070
0413-2615457
info@mgmcri.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hoffer Q formula  It is known to be one of the most accurate formulas in this range. 
Intervention  Kane formula  It combines theoretical optics with modern data science techniques, including artificial intelligence. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adults undergoing uneventful SICS with posterior chamber intraocular lens (IOL) implantation.
Axial length less than 22.0 mm as measured by A-scan biometry.
Willingness to participate and attend follow-up visits.
 
 
ExclusionCriteria 
Details  Prior ocular surgery or trauma.
Intraoperative or postoperative complications.
Eyes with corneal opacities or irregular astigmatism..
Patients who have undergone refractive & retinal surgeries.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post operative refractive error accuracy of the Hoffer Q and Kane formulas in short eyes.  At the time of discharge at day 1 postoperatively
At 1 week postoperatively
At 4 weeks postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/09/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

This randomized controlled trial compares the visual and refractive outcomes of intraocular lens (IOL) power calculation in short eyes (axial length <22 mm) using two different formulas: the traditional Hoffer Q formula and the AI-based Kane formula. Accurate IOL power prediction in short eyes remains a challenge due to anatomical variations. The study aims to evaluate which formula provides more precise postoperative visual outcomes, reduced refractive error, and overall better predictability in cataract surgery for short eyes.

 
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