Delayed Visual Maturation: Outcome and Predictive Factors (DVM)

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

Study Overview

• Status: Completed
• Conditions: Delayed Visual Maturation

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
delayed visual maturation; children with delayed visual maturation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	1998-2016
ophthalmological problems	by questionnaire : visual problems, wearing glasses? taped eyes?	1998-2016
Visual acuity	assested at the last consultation indicated in Snellen	1998-2016

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Ingele Casteels, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: delayed visual maturation
• Other Study ID Numbers: S62961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No