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

Sponsor

Holhos Larisa Bianca (Other)

Overall Status

Completed

CT.gov ID

NCT04827511

Collaborator

(none)

161

Enrollment

Location

26.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Child, Only	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

161 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Refractive Disorders and Seric Vitamin D Level in Children With Disabilities

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Refractive disorders in children with disabilities [1 January 2019-31 August 2020]
Prevalence of refractive disorders in children with disabilities

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

children with disabilities and healthy children

Exclusion Criteria:

children diagnosed with another chronic diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Holhoș Larisa Bianca	Marghita	Bihor	Romania	415300

Sponsors and Collaborators

Holhos Larisa Bianca

Investigators

Principal Investigator: Holhoș L Bianca, Doctor, Faculty of Medicine and Pharmacy Oradea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Holhos Larisa Bianca, Specialist in Ophthalmology, Elisantes Teola SRL

ClinicalTrials.gov Identifier:

NCT04827511

Other Study ID Numbers:

142312202069

First Posted:

Apr 1, 2021

Last Update Posted:

Apr 5, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Holhos Larisa Bianca, Specialist in Ophthalmology, Elisantes Teola SRL

disability, healthy

Additional relevant MeSH terms:

Refractive Errors

Study Results

No Results Posted as of Apr 5, 2021