NCT04827511

Completed

Refractive Disorders and Seric Vitamin D Level in Children W...

Holhos Larisa Bianca Source

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Other study identifiers

Sponsor study identifier

142312202069

Study Type

observational

Actual enrollment (reported)

161

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2019

Actual (reported)

Primary Completion

August 31, 2020

Actual (reported)

Study Completion

March 31, 2021

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 161 participants
Study completion date: March 31, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2019
Actual (reported)
Primary Completion
August 31, 2020
Actual (reported)
First Submitted
March 30, 2021
Actual (reported)
Study Completion
March 31, 2021
Actual (reported)
First Posted
April 1, 2021
Actual (reported)

Last Updated: April 5, 2021
Status Verified: April 2021
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

Holhos Larisa Bianca
Otherlead

Study Sites (1)

Holhoș Larisa Bianca

Marghita, Bihor County, 415300, Romania

Study Officials

Holhoș L Bianca, Doctor
Faculty of Medicine and Pharmacy Oradea
PRINCIPAL INVESTIGATOR

Enrollment

161 participants (actual enrollment reported by the registry).

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

Actual (reported)

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children diagnosed with another chronic diseases

Contact the study team to confirm eligibility.

Primary Completion

August 31, 2020

Actual (reported)

Study Completion

March 31, 2021

Actual (reported)

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing: Will share
Shared Documents: CSR
Time Frame: 20/10/2021-20/10/2031
Access Criteria: by invitation

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04827511
Data provider: ClinicalTrials.gov
Source updated: 2021-04-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:45 UTC

Locations

RO(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

cohort group

control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations