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CTRI Number  CTRI/2023/08/056892 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Vision assessment in pre-schoolers with Speech and language delay associated with screen time 
Scientific Title of Study   Ocular profiling in pre-schoolers with speech and language delay associated with screen time 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swathi Shenoy K 
Designation  Student persuing Master of Optometry 
Affiliation  Manipal College of Health Professions 
Address  Department of Optometry, Manipal College of Health Professions (MCHP),Manipal-576104, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  6364371781  
Fax    
Email  swathi.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Salai Dhavamathi J 
Designation  Assistant professor-Senior scale 
Affiliation  Manipal College of Health Professions 
Address  Department of Optometry, MCHP, MAHE,Manipal-576104, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9176654452  
Fax    
Email  dhavamathi.j@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Swathi Shenoy K 
Designation  Student persuing Master of Optometry 
Affiliation  Manipal College of Health Professions 
Address  Department of Optometry, MCHP, MAHE,Manipal-576104, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  6364371781  
Fax    
Email  swathi.mchpmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576104, Karnataka, India 
 
Primary Sponsor  
Name  Swathi Shenoy K 
Address  Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576104, Karnataka, India 
Type of Sponsor  Other [Self-sponsered] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swathi Shenoy K  Kasturba Hospital  Optometry Clinic,Room number 314, 3rd floor,Baliga block (CTC building), Kasturba hospital,Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 		 6364371781

swathi.mchpmpl2022@learner.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-2 (student research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Pre-schoolers between the age of 3-6 years, clinically diagnosed with speech and language delay associated with increased screen time exposure based on the screen Q questionnaire 
 
ExclusionCriteria 
Details  Pre-schoolers associated with any systemic disease, any ocular pathology and preschoolers with any neurological condition or developmental delay will  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Near point of accommodation (NPA) in diopters, near point of convergence (NPC) in diopter, Negative relative accommodation (NRA) in diopter, Positive relative accommodation (PRA) in diopter, Phoria assessment using cover test in prism diopter, tropia assessment using Hirschberg test in prism diopter, Lag/lead of accommodation in Diopter, Stereopsis in seconds per arc  All the outcomes will be measured in the single day  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/09/2023 
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 Applicable 
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   Institutional Research committee approval is obtained. Approval from Department of Speech and hearing is obtained. Approval from Institutional Ethics committee will be obtained followed by registration in Clinical trial registry of India. Screen Q questionnaire is used to select the participants for the study. Response to this questionnaire is given by parent or caretaker. Permission from the original test author has been obtained to translate, adapt and validate Screen Q questionnaire into kannada language. To serve this purpose screen Q questionnaire will be administered on parents of normal children without speech language delay from the local community (neighbors and siblings of study participants). This questionnaire does not include any personal information; thus, the questionnaire responses are completely anonymous. If patient denies to respond this questionnaire there will not be any penalty or loss of benefits. Completion this questionnaire requires approximately 10 minutes. It includes questions regarding type of digital device used by child, does the child suffer from any medical condition, does the child have any special needs. Study participants includes pre-schoolers between the age of 3-6 years of age, clinically diagnosed with speech and language delay associated with screen time. Study participants will be directly recruited from Department of Speech and hearing. After selection of subjects, informed consent is obtained from parents. During the visit of subjects, detailed history taking will be done, history taking includes birth history, ocular history, systemic history, family history. followed by slit lamp examination, assessing distance and near visual acuity using log MAR chart, objective refraction will be done to assess the presence of refractive error. During the same visit, ocular profiling will be done using different tests like Cover test, Hirschberg test, Extra ocular motility test, near point of accommodation (NPA), Near point of convergence (NPC), Lag /lead of accommodation, Negative relative accommodation (NRA), Positive relative accommodation (PRA), Stereopsis. Subjects will not have any follow up all the test procedure will be completed during their first visit only. 
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