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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04251338
Other study ID # S62961
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2019
Est. completion date February 10, 2020

Study information

Verified date January 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date February 10, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Universitaire Ziekenhuizen Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary delayed visual maturation. the prevalence of developmental problems in children with delayed visual maturation. 1998-2016
Secondary Level of development by questionnaire:type of education/school , problems with writing, mathematics: yes or no 1998-2016
Secondary Fine and gross motor skills by questionnaire: physiotherapy needed yes or no 1998-2016
Secondary ophthalmological problems by questionnaire : visual problems, wearing glasses? taped eyes? 1998-2016
Secondary Visual acuity assested at the last consultation indicated in Snellen 1998-2016
See also
  Status Clinical Trial Phase
Completed NCT02890251 - Visual Maturation in Premature Newborns According to Factors Influencing Its Development