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CTRI Number  CTRI/2025/11/098173 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Practice sessions to train non-dominant hand functionality for surgical skill improvement]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Studying how different training techniques help eye surgery trainees improve the function and coordination of their non-dominant hand over a few weeks, assessed using a surgical simulator 
Scientific Title of Study   A comparative analysis of training methods for non-dominant hand proficiency in ophthalmic surgery using simulated surgical tasks : A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Karthikeyan Mahalingam 
Designation  Assistant Professor , Ophthalmology 
Affiliation  JIPMER  
Address  Near ward 24 Ophthalmology block Old hospital building JIPMER hospital Gorimedu, Dhanvantari Nagar, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9791133525  
Fax    
Email  kalingachit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shrey Shah 
Designation  Junior Resident , Ophthalmology 
Affiliation  JIPMER  
Address  Ward 24 Ophthalmology block old building JIPMER hospital Gorimedu, Dhanvantari Nagar, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  6354831758  
Fax    
Email  shahshrey8142@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Shrey Shah 
Designation  Junior Resident , Ophthalmology 
Affiliation  JIPMER  
Address  Ward 24, Ophthalmology block old building, JIPMER hospital Gorimedu, Dhanvantari Nagar, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  6354831758  
Fax    
Email  shahshrey8142@gmail.com  
 
Source of Monetary or Material Support  
Intramural Research Fund Committee, JIPMER, Puducherry.  
 
Primary Sponsor  
Name  Intramural Research Fund Committee, JIPMER, Puducherry.  
Address  Gorimedu, Dhanvantari Nagar, Puducherry, 605006. JIPMER 
Type of Sponsor  Research institution and hospital 
 
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 SHREY SHAH   JIPMER   Ward 22/24, Ophthalmology department, old hospital block,JIPMER hospital, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY 		 6354831758

shahshrey8142@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE - INTERVENTIONAL STUDIES JIPMER , PUDUCHERRY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Baseline (Pre-Training) Assessment   All participants will undergo baseline assessment of their non-dominant hand performance on a surgical simulator before training. The post-training performance after 3 weeks will be compared with baseline to measure improvement.  
Intervention  Dry Lab Simulator Training  Participants will practice simulated surgical tasks using their non-dominant hand on a dry lab surgical simulator for 30 minutes per day, 5 days a week, for 3 weeks. Improvement in hand function and surgical precision will be evaluated through simulator scores. 
Intervention  Non-Dominant Hand Daily Activities   Participants will perform daily activities such as brushing, eating, or combing hair using their non-dominant hand for 30 minutes per day, 5 days a week, for 3 weeks. This aims to enhance basic motor coordination and dexterity of the non-dominant hand.  
Intervention  Wet Lab Training  Participants will practice surgical steps using their non-dominant hand in wet lab for 30 minutes per day, 5 days a week, for 3 weeks. The aim is to improve coordination and control of the non-dominant hand for ophthalmic surgical skills. 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Residents and interns
Best corrected visual acuity - 6/6 in both eyes 
 
ExclusionCriteria 
Details  Participants with prior non-dominant hand training
Any neuromuscular disease which can affect the training
Participants not willing for 3 weeks training
Ocular deviation affecting stereopsis  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy of different non-dominant hand training methods in improving performance in ophthalmic surgery   Baseline (before training) and after 3 weeks of training.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Surgical task scores obtained by non-dominant hand and dominant hand before and after training of non-dominant hand   Baseline (before training) and after 3 weeks of training.
 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   15/12/2025 
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="3"
Days="0" 
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 - NO
Brief Summary   This randomized controlled trial aims to compare the effectiveness of three training methods for improving non-dominant hand proficiency in ophthalmic surgery. Participants will be randomized into three groups:  wet lab practice, dry lab simulator training, and daily non-dominant hand activities. Each training method will be conducted for 30 minutes per day, five days per week, over three weeks. Improvement in surgical performance will be assessed using a validated virtual reality surgical simulator. The study seeks to identify the most effective training approach for enhancing non-dominant hand skills among ophthalmology trainees. 
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