NCT04827511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

March 30, 2021

Last Update Submit

April 1, 2021

Conditions

Child, Only

Keywords

disability, healthy

Outcome Measures

Primary Outcomes (1)

  • Refractive disorders in children with disabilities

    Prevalence of refractive disorders in children with disabilities

    1 January 2019-31 August 2020

Study Arms (2)

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

control group

81 healthy children, not known or diagnosed with a chronic disease of any kind

Other: Refraction measurement with auto-ref-keratometer Canon

Interventions

Refraction measurement with auto-ref-keratometer CanonOTHER

Refractive measurement and vitamin D level dosing

cohort groupcontrol group

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • children with disabilities and healthy children

You may not qualify if:

  • children diagnosed with another chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holhoș Larisa Bianca

Marghita, Bihor County, 415300, Romania

Location

Study Officials

  • Holhoș L Bianca, Doctor

    Faculty of Medicine and Pharmacy Oradea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
19 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist in Ophthalmology

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

January 1, 2019

Primary Completion

August 31, 2020

Study Completion

March 31, 2021

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Reports from the statistical analysis

Shared Documents
CSR
Time Frame
20/10/2021-20/10/2031
Access Criteria
by invitation

Locations

RO(1)