| 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
|
|
|
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
|
|
|
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. |