| CTRI Number |
CTRI/2024/08/072128 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Opinions and treatment patterns of nearsightedness among eyecare specialists in India |
|
Scientific Title of Study
|
Perception and practice trends of myopia management among eyecare practitioners in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Sakshi Priya |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions(MCHP) |
| Address |
Room no: 313, Department of Optometry, Manipal College of Health
Professions (MCHP), Manipal Academy of Higher Education
(MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9641439530 |
| Fax |
|
| Email |
sakshi2.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krithica S |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Health Professions(MCHP) |
| Address |
Room no: 313, Department of Optometry, Manipal College of Health
Professions (MCHP), Manipal Academy of Higher Education
(MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8861330980 |
| Fax |
|
| Email |
krithica.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krithica S |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Health Professions(MCHP) |
| Address |
Room no: 313, Department of Optometry, Manipal College of Health
Professions (MCHP), Manipal Academy of Higher Education
(MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8861330980 |
| Fax |
|
| Email |
krithica.s@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no. 313
Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of
Higher Education (MAHE), Manipal, 576104
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Ms Sakshi Priya |
| Address |
Room no: 313,
Department of Optometry, Manipal College of Health
Professions (MCHP), Manipal Academy of Higher Education
(MAHE),
Manipal, 576104
Karnataka, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Krithica S |
Optometry clinic |
Room no: 315,
Department of
Optometry, CTC Block,
Kasturba Hospital,
Manipal Academy of
Higher Education
(MAHE), Manipal, 576104
Udupi
KARNATAKA |
8861330980
krithica.s@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Myopia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Eyecare practitioners (Optometrists, Ophthalmologists and Opticians) currently practising in India
2. Minimum of 2 years of clinical practice |
|
| ExclusionCriteria |
| Details |
Individuals currently not involved in clinical practice |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Descriptive statistics of the scores of Perception and Practice patterns |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="590"
Sample Size from India="590"
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)
|
16/08/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Current evidence
shows an increasing trend of incidence of myopia since last 10 years. The
progression of myopia is an major problem that can be controlled by various
treatment modalities. The practice patterns followed by eyecare practitioners
(Optometrists, Ophthalmologists and Opticians) in India is quiet varied in the
evaluation and management of myopia. Current published literature has assessed
the practice patterns only among optometrists in India and there is a need to
understand the same among all various vision care providers. This study will
aid in understanding the practice
patterns and perceptions of myopia management among all types of eyecare
practitioners like ophthalmologists, optometrists and opticians in India. This is help us understand the diversity in
the practice patterns and the need for continuous training program that will
help in the appropriate management of myopia among all eye care practitioners. The
study is an online questionnaire-based survey. It has 16 items in total. It
will be circulated as google forms to all eye care practitioners through
national level associations and social media groups. It will take 15 mins to complete the questionnaire. The first and
second reminder will be sent with one month time interval. The collected data will be screened for completeness
and duplication before proceeding with further analysis. |