| CTRI Number |
CTRI/2022/09/045511 [Registered on: 14/09/2022] Trial Registered Prospectively |
| Last Modified On: |
13/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of knowledge, attitude and practice among parents of children with lazy eye and teaching them regarding the disease. |
|
Scientific Title of Study
|
Assessment of knowledge, attitude and practice among parents of children with Amblyopia and educating them regarding the disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monalisa Saha |
| Designation |
Secondary DNB resident |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital, Cuddalore Main Road,Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9886372369 |
| Fax |
|
| Email |
monalisasaha.d@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Veena |
| Designation |
Head of the department, Paediatric Ophthalmology and Squint services |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital, Cuddalore Main Road,Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9442891143 |
| Fax |
|
| Email |
veena@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Veena |
| Designation |
Head of the department, Paediatric Ophthalmology and Squint services |
| Affiliation |
Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital, Cuddalore Main Road,Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9442891143 |
| Fax |
|
| Email |
veena@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Monalisa Saha |
| Address |
Aravind Eye Hospital, Cuddalore Main Road. 605007 |
| Type of Sponsor |
Other [Post graduate trainee] |
|
|
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 Monalisa Saha |
Paediatric Ophthalmology and Squint Services, Aravind Eye Hospital, Pondicherry |
Aravind Eye Hospital, Cuddalore Main Road,Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY |
9886372369
monalisasaha.d@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parents of amblyopic children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All parents accompanying a child aged 5–15 years of age who were diagnosed for the first time as Amblyope were approached and invited to participate in the study before any awareness campaign material was provided.Based on the answers a score will be calculated separately for knowledge, attitude and practices of these parents and following this an informative video will be shown to the parents and the same questions will be repeated again.After collecting the responses statistical analysis will be done to compare the knowledge, attitude and practice among the parents.
|
|
| ExclusionCriteria |
| Details |
1.Children with retinal, macular, optic nerve pathology
2.Children with special needs, developmental delay, systemic problem
3.Children less than 5 years of age
Parents who are acquainted to the field of ophthalmology by virtue of their profession.
4.Parents unwilling to participate in the study.
5.Parents who have themselves undergone treatment for Amblyopia.
6.Parents who have another child suffering from or have been treated for Amblyopia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the knowledge among parents of amblyopes about Amblyopia and its effects on their childs development. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To fill up the gaps in their concepts about the various aspects of Amblyopia. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
18/09/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
On completion of the trial this study will be considered for a publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are conducting this cross sectional questionnaire based study to assess the pre-existing knowledge, attitude and practice among the parents of amblyopes about Amblyopia and we are imparting education regarding the same following that. After educating the parents we are reassessing the status of their awareness regarding Amblyopia and the effect it will have on their children. We hope to impart education regarding this issue and spread awareness regarding the same through the process. |