| CTRI Number |
CTRI/2023/07/055662 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to collect Normal values for different components of vision among school children . |
|
Scientific Title of Study
|
Development of Normative Data using Test for Visual Perceptual Skills -4 (TVPS-4) among school children of age 7-10 years in Udupi taluk |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja P L |
| Designation |
Master of Optometry |
| Affiliation |
Manipal College of Health Professions |
| 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 |
6379369845 |
| Fax |
0 |
| Email |
pooja.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krithica S |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room 313,Department of Optometry , Manipal College of Health Professions(MCHP),Manipal Academy of Higher Education(MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8861330980 |
| Fax |
0 |
| Email |
krithica.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krithica S |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| 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 |
0 |
| Email |
krithica.s@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of optometry , Manipal College Of health professions (MCHP) , Manipal Academy of Higher Education (MAHE), Manipal . |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of optometry , Manipal College Of health professions (MCHP) , Manipal Academy of Higher Education (MAHE), Manipal . |
| 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 |
Manipal College Of Health Professions |
Room No .313,Department of Optometry, Manipal college of Health Professions , Block 2 , Madhav Nagar , Manipal -576104
Udupi
KARNATAKA |
8861330980
0
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 |
Normals without any ocular diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in age group 7 to 12 years from English and Kannada medium of government-aided and unaided schools.
2. Both gender
3. Presenting visual acuity of 6/6 or better
4. Near visual acuity of N6 |
|
| ExclusionCriteria |
| Details |
1.Histroy of developmental Delay as reported by a teacher or observed by an examiner.
2. presence of tropia.
3. child unable to follow instructions and perform test.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Develop normative data of visual perception using TVPS-4 in school children between 7 -10 years in Udupi taluk. |
1 year |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="420"
Sample Size from India="420"
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)
|
02/08/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Visual perception deficit
can influence a child’s activities of daily living, education, work, play, and social participation. To find
such deficits, normative data is essential, there are only two normative data in the US population and Hong
Kong population, and in India, no normative data is available for TVPS-4 as visual perception is culture-specific. So this study helps to collect normative data for 7 to 10 years of school-going children in Udupi taluk. Developing Indian normative data will help to find children with abnormal visual perception based on it; vision therapies can be given on that particular skill. |