Delayed Visual Maturation: Outcome and Predictive Factors | NCT04251338

Studies
Delayed Visual Maturation: Outcome and Predictive Factors

NCT04251338

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

May 8, 2020Actual

Enrollment

71Actual

Phase

Not provided

Conditions

Delayed Visual Maturation

Interventions

Not provided

Countries

Belgium

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

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

Sep 3, 2019Actual

Primary Completion Date

Feb 10, 2020Actual

Completion Date

Feb 10, 2020Actual

First Submitted Date

Dec 31, 2019

First Submission Date that Met QC Criteria

Jan 30, 2020

First Posted Date

Jan 31, 2020Actual

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

May 7, 2020

Last Update Posted Date

May 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation.

Detailed Description

description of the developmental outcome of children with delayed visual maturation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Label	Type	Description	Intervention Names
delayed visual maturation		children with delayed visual maturation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
delayed visual maturation.	the prevalence of developmental problems in children with delayed visual maturation.	1998-2016

Secondary Outcomes

Measure	Description	Time Frame
Level of development	by questionnaire:type of education/school , problems with writing, mathematics: yes or no	1998-2016
Fine and gross motor skills	by questionnaire: physiotherapy needed yes or no

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants (male or female) with suboptimal/absent visual contact at the age of ≥3 months, without other known general developmental delay at the time diagnosis of delayed visual contact and without anatomic ocular abnormalities at the initial ophthalmological examination.

Exclusion Criteria:

Children with known underlying psychomotor developmental delay or epilepsy at first ophthalmic consultation.
Children with ophthalmic (anatomical) abnormalities that explain delayed visual maturation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

patients seen in UZ Leuven between 1998 and 2016 with diagnosis of delayed visual maturation who meet the inclusion criteria.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingele Casteels, PhD	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaire Ziekenhuizen Leuven		Leuven		3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jun 22, 2022
Reset	Apr 11, 2023
Release	May 4, 2023
Reset	Jan 24, 2024

Submission Tracking

Estimated Results First Submitted Date

Jun 22, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 22, 2022			Apr 11, 2023
May 4, 2023