Refractive Disorders and Seric Vitamin D Level in Childre... | NCT04827511

Studies
Refractive Disorders and Seric Vitamin D Level in Children With Disabilities

NCT04827511

Sponsor

Holhos Larisa Bianca

Status

Completed

Last Update Posted

Apr 5, 2021Actual

Enrollment

161Actual

Phase

Not provided

Conditions

Child, Only

Interventions

Refraction measurement with auto-ref-keratometer Canon

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Aug 31, 2020Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Mar 30, 2021

First Submission Date that Met QC Criteria

Mar 30, 2021

First Posted Date

Apr 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2021

Last Update Posted Date

Apr 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

19 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Refraction measurement with auto-ref-keratometer Canon	Other	Refractive measurement and vitamin D level dosing	cohort group control group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with disabilities and healthy children

Exclusion Criteria:

children diagnosed with another chronic diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Holhoș L Bianca, Doctor	Faculty of Medicine and Pharmacy Oradea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holhoș Larisa Bianca		Marghita	Bihor County	415300	Romania

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Reports from the statistical analysis

Types

Clinical Study Report (CSR)

Time Frame

20/10/2021-20/10/2031

Access Criteria

by invitation

URL

Not provided