Vision assessment in pre-schoolers with Speech and language delay associated with screen time
- Conditions
- Other specified disorders of eye and adnexa,
- Registration Number
- CTRI/2023/08/056892
- Lead Sponsor
- Swathi Shenoy K
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
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.
Pre-schoolers associated with any systemic disease, any ocular pathology and preschoolers with any neurological condition or developmental delay will.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Not applicable Not applicable
Trial Locations
- Locations (1)
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Hospital🇮🇳Udupi, KARNATAKA, IndiaDr Swathi Shenoy KPrincipal investigator6364371781swathi.mchpmpl2022@learner.manipal.edu