Premavision Cohort Follow-up

Not Applicable

Terminated

• Conditions: Visual Disorder

• Registration Number: NCT03207477
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Study Start: 2017-11-20
• Primary Completion: 2020-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual acuity measurement	7 years post-natal age	Parinaud and Snellen tests

Secondary Outcome Measures

Name	Time	Method
Measurement of cyclopegic refraction	7 years of age	Non invasive refraction measurement by autorefractometer

Trial Locations

Locations (1)

Maternity Hospital CHRU; 🇫🇷 Nancy, France