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NCT04827511 Clinical Trial

Refractive Disorders and Seric Vitamin D Level in Children With Disabilities

Child, Only Clinical Trial

— REDIC  

Official title:
Refractive Disorders and Seric Vitamin D Level in Children With Disabilities

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04827511
Other study ID # 142312202069
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date March 31, 2021

Study information
Verified date April 2021
Source Elisantes Teola SRL
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The investigator want to determine the refractive status of 80 children with disabilities and of 81 healthy children from a witness group. The vitamin D level of the children will be dosed for making different correlations with visual acuity status.

Description:

Refraction measurement will be done by the investigator in all 161 children. Visual acuity is checked, initial and after correction with proper correction. Vitamin D level is dosed from all the children in order to make correlations with the visual acuity, refractive status and risk for visual impairment.

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date March 31, 2021
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 16 Years
Eligibility Inclusion Criteria: - children with disabilities and healthy children Exclusion Criteria: - children diagnosed with another chronic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Refraction measurement with auto-ref-keratometer Canon
Refractive measurement and vitamin D level dosing

Locations
Country Name City State
Romania Holho? Larisa Bianca Marghita Bihor

Sponsors (1)
Lead Sponsor Collaborator
Holhos Larisa Bianca

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Refractive disorders in children with disabilities Prevalence of refractive disorders in children with disabilities 1 January 2019-31 August 2020
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