Premavision Cohort Follow-up

Visual Disorder Clinical Trial

— PrmvsionSuiv  

Official title:

Visual Maturation in Prematurely Born Infants According to Factors Influencing Its Development. Premavision Follow-up at 18 Months Corrected Age, 4 and 7 Years of Age.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03207477
• Other study ID #: 2016-A02017-44
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim at following a cohort of prematurely born infants at 18 months corrected age, 4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent age (TEA) with factors associated with impaired visual maturation. (PREMAVISION-CLinicalTrials.gov ID: NCT02890251).

In this follow-up study, prematurely born infants vision will be compared to term born infants matched for postnatal age.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 7 Years

Eligibility

Inclusion Criteria:

• Infants included in the Premavision cohort

• Term born healthy control infants at matched postnatal age

Exclusion Criteria:

• Ocular malformation

• Genetic abnormality

• Neurodevelopmental impairment

Related Conditions & MeSH terms

• Vision Disorders
• Visual Disorder

Intervention

Diagnostic Test:
• Visual acuity measurement
visual acuity measurement by Baby Vision cards at 18 months corrected age, by Rossano Weiss test at 4 years of age and optometric tests of Parinaud and Snellen at 7 years of age

Locations

Country	Name	City	State
France	Maternity Hospital CHRU	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity measurement	Baby Vision Cards	18 months corrected age
Primary	Visual acuity measurement	Rossano Weiss test	4 years post-natal age
Primary	Visual acuity measurement	Parinaud and Snellen tests	7 years post-natal age
Secondary	Measurement of cyclopegic refraction	Non invasive refraction measurement by autorefractometer Cycloplégie par Skiacol	18 months corrected age
Secondary	Measurement of cyclopegic refraction	Non invasive refraction measurement by autorefractometer	4 years of age
Secondary	Measurement of cyclopegic refraction	Non invasive refraction measurement by autorefractometer	7 years of age