| CTRI Number |
CTRI/2021/08/036080 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
27/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Questionnaire based study |
| Study Design |
Other |
|
Public Title of Study
|
A questionnaire-based study to examine the impact of the COVID-19 pandemic on contact lens wearers |
|
Scientific Title of Study
|
The impact of the pandemic of COVID-19 on contact lens users - a questionnaire-based study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
THASMIA |
| Designation |
Master of optometry, Student |
| Affiliation |
Manipal College of health Professions.MAHE |
| Address |
Dept. of Optometry, Manipal College of health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9632841214 |
| Fax |
|
| Email |
thasmia.mcoahsma1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Premjit bhakat |
| Designation |
Assistant Professor-senior scale |
| Affiliation |
Manipal college of health professions. |
| Address |
Dept. of Optometry, Manipal College of health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742503244 |
| Fax |
|
| Email |
premjit.bhakat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Premjit bhakat |
| Designation |
Assistant Professor-senior scale |
| Affiliation |
Manipal college of health professions. |
| Address |
Dept. of Optometry, Manipal College of health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742503244 |
| Fax |
|
| Email |
premjit.bhakat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal college of health professions |
| Address |
Dept. of Optometry, Manipal College of health Professions,
Manipal Academy of Higher Education, Manipal, 576104 |
| 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 |
| Thasmia |
Manipal college of health professions |
Dept. of Optometry, Manipal College of health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
09632841214
thasmia.mcoahsma1@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and kasturba hospital institutional committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CONTACT LENS USERS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Existing Contact lens users
Age group 18 years and above
Contact lens user from 2019 or before (minimum one year of contact lens use)
|
|
| ExclusionCriteria |
| Details |
Therapeutic users
Occasional contact lens users
Previous ocular surgery
Eye disease – dry eye disease, infection and inflammation related disease
Neurological disease – optic neuritis, night or day blindness, color blindness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency/number of people reported, Behavior, attitude, and concerns of the contact lens users. |
The questionnaire will be administrated at one point of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="289"
Sample Size from India="289"
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)
|
20/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SARS-CoV-2 or severe acute respiratory syndrome coronavirus causes COVID-19, WHO provided a greater emphasis on hand hygiene, face protection, and avoidance of touching face, mouth, and eyes to restrict the spread of this novel virus. This led to a significant shift in social interaction and change in everyday lives, including contact lens wear and practice by the individual. The recent update provided to the contact lens users is that the contact lens wear is safe until optimum hand hygiene is practiced during handling lenses and discontinued if unwell. The non-compliance of contact lens users is a global issue. There is a lack of data concerning the conduct and behavior of users of the contact lens. This study aims to gather evidence during the COVID-19 pandemic on the perception, behavior, and attitude among contact lens users. This study will build confidence among eye care professionals to improve the management and reduce the risk of complications related contact lenses. |