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Delayed Visual Maturation: Outcome and Predictive Factors (DVM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251338
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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

Condition or disease
Delayed Visual Maturation

Detailed Description:
description of the developmental outcome of children with delayed visual maturation.

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Delayed Visual Maturation: Outcome and Predictive Factors
Actual Study Start Date : September 3, 2019
Actual Primary Completion Date : February 10, 2020
Actual Study Completion Date : February 10, 2020

Group/Cohort
delayed visual maturation
children with delayed visual maturation



Primary Outcome Measures :
  1. delayed visual maturation. [ Time Frame: 1998-2016 ]
    the prevalence of developmental problems in children with delayed visual maturation.


Secondary Outcome Measures :
  1. Level of development [ Time Frame: 1998-2016 ]
    by questionnaire:type of education/school , problems with writing, mathematics: yes or no

  2. Fine and gross motor skills [ Time Frame: 1998-2016 ]
    by questionnaire: physiotherapy needed yes or no

  3. ophthalmological problems [ Time Frame: 1998-2016 ]
    by questionnaire : visual problems, wearing glasses? taped eyes?

  4. Visual acuity [ Time Frame: 1998-2016 ]
    assested at the last consultation indicated in Snellen



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251338


Locations
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Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Ingele Casteels, PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04251338    
Other Study ID Numbers: S62961
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
delayed visual maturation