Refractive Disorders and Seric Vitamin D Level in Children With Disabilities (REDIC)

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.

Study Overview

• Status: Completed
• Conditions: Child, Only
• Intervention / Treatment: Other: Refraction measurement with auto-ref-keratometer Canon

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Romania
  • Bihor
    • Marghita, Bihor, Romania, 415300
      • Holhoș Larisa Bianca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

80 children with disabilities like ADHD, autism, Down syndrome, deafness, phocomelia and 81 clinically healthy children

Description

Inclusion Criteria:

• children with disabilities and healthy children

Exclusion Criteria:

• children diagnosed with another chronic diseases

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cohort group; 80 children with disabilities like autism, ADHD, Down syndrome, deafness, phocomelia, dyslexia, different motor problems	Other: Refraction measurement with auto-ref-keratometer Canon; Refractive measurement and vitamin D level dosing
control group; 81 healthy children, not known or diagnosed with a chronic disease of any kind	Other: Refraction measurement with auto-ref-keratometer Canon; Refractive measurement and vitamin D level dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive disorders in children with disabilities	Prevalence of refractive disorders in children with disabilities	1 January 2019-31 August 2020

Collaborators and Investigators

• Sponsor: Holhos Larisa Bianca
• Investigators: Principal Investigator: Holhoș L Bianca, Doctor, Faculty of Medicine and Pharmacy Oradea

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: disability, healthy
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: 142312202069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Reports from the statistical analysis
• IPD Sharing Time Frame: 20/10/2021-20/10/2031
• IPD Sharing Access Criteria: by invitation
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No