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CTRI Number  CTRI/2024/10/075803 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Understanding MBBS Students Preferences for Vision Correction Methods 
Scientific Title of Study   Perception of Refractive Error Correction Methods among Phase I & Phase II MBBS Students. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prisha 
Designation  MBBS Student 
Affiliation  Adesh Medical College And Hospital 
Address  096/2021, MBBS Student, Adesh Medical College And Hospital, Shahbad (M)
Adesh Medical College And Hospital, Shahbad (M)
Kurukshetra
HARYANA
136135
India 
Phone  7009303093  
Fax    
Email  prisha.ind@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Punita Garg 
Designation  Professor & Head, Ophthalmology 
Affiliation  Adesh Medical College And Hospital 
Address  HOD Office Department of Ophthalmology, Adesh Medical College And Hospital, Shahbad (M)
Adesh Medical College And Hospital, Shahbad (M)
Kurukshetra
HARYANA
136135
India 
Phone  8708649738  
Fax    
Email  drpgargmmu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Punita Garg 
Designation  Professor & Head, Ophthalmology 
Affiliation  Adesh Medical College And Hospital 
Address  HOD Office Department of Ophthalmology, Adesh Medical College And Hospital, Shahbad (M)
Adesh Medical College And Hospital, Shahbad (M)
Kurukshetra
HARYANA
136135
India 
Phone  8708649738  
Fax    
Email  drpgargmmu@gmail.com  
 
Source of Monetary or Material Support  
University Undergraduate Research Scheme (UURS), Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak, Haryana 124001. INDIA 
 
Primary Sponsor  
Name  Adesh Medical College And Hospital 
Address  Adesh Medical College And Hospital, Shahbad (M), Dist. Kurukshetra 136135  
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 
Dr Punita Garg  Adesh Medical College And Hospital  HOD Ophthalmology Office, First Floor, OPD Block, Adesh Medical College And Hospital, Shahbad (M), 136135
Kurukshetra
HARYANA 
8708649738

drpgargmmu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical & Health Research (IEC-BHR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Perception of Refractive Error Correction Methods among Phase I & Phase II MBBS Students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Phase I, MBBS students: To study the perceptions of refractive error correction methods amongst Phase I, MBBS students  Perceptions of refractive error correction methods, such as spectacles, contact lenses, and surgical interventions like LASIK amongst Phase I, MBBS students 
Comparator Agent  Phase II, MBBS students: To study the perceptions of refractive error correction methods amongst Phase II, MBBS students  Perceptions of refractive error correction methods, such as spectacles, contact lenses, and surgical interventions like LASIK amongst Phase II, MBBS students 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Eligibility criteria include being a phase I and phase II MBBS student and providing informed consent to participate in the study. 
 
ExclusionCriteria 
Details  There will be no exclusion criteria based on age, gender, or previous ocular history. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess how Phase I and Phase II MBBS students perceive the effectiveness, comfort, and convenience of various refractive error correction methods (spectacles, contact lenses, refractive surgery).  Pilot Testing: Duration: 1 week
Participant Recruitment: Duration: 4 weeks
Questionnaire Administration: Duration: 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate how demographic factors (e.g., age, gender, socioeconomic status) influence the choice of refractive error correction methods (spectacles, contact lenses, refractive surgery) between Phase I & Phase II MBBS students.  Pilot Testing: Duration: 1 week
Participant Recruitment: Duration: 4 weeks
Questionnaire Administration: Duration: 2 weeks 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   11/11/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study aims to investigate the perception and acceptance of refractive error correction methods among Phase I and Phase II MBBS students at Adesh Medical College and Hospital, Shahbad, Kurukshetra. Utilizing a descriptive cross-sectional design, the research will assess preferences for spectacles, contact lenses, and refractive surgery, taking into account participants’ demographic details. The study hypothesizes that significant differences in perceptions will exist between students from urban and rural settings. It is anticipated that urban students will show a greater preference for contact lenses and refractive surgery due to factors such as convenience and lifestyle, while rural students may favor spectacles because of accessibility and cost considerations.

To gather data on participants’ demographics, knowledge of refractive errors, and preferences for correction methods, structured questionnaires will be administered through Google Forms. Ethical measures will ensure voluntary participation, confidentiality, and the right to withdraw without consequences. Data analysis will include descriptive statistics and comparative analysis to draw insights into the factors influencing choices among these future medical professionals.

Understanding urban-rural differences in perception can inform strategies to improve access to eye care services for rural populations and address disparities in vision correction. Ultimately, this research seeks to provide valuable insights that can assist in revising educational interventions, clinical practices, and healthcare policies aimed at promoting optimal vision care practices.

References:

Alhibshi N, Kamal Y, Aljohany L, Alsaeedi H, Ezzat S, Mandora N. Attitude toward refractive error surgery and other correction methods: A cross-sectional study. Ann Med Surg (Lond). 2021 Nov 24; 72: 103-104.

 
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