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Clinical Trials/NCT03207477
NCT03207477
Terminated
Not Applicable

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.

Central Hospital, Nancy, France1 site in 1 country37 target enrollmentNovember 20, 2017
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ConditionsVisual Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Visual Disorder
Sponsor
Central Hospital, Nancy, France
Enrollment
37
Locations
1
Primary Endpoint
Visual acuity measurement
Status
Terminated
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2017
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Jean-Michel HASCOET

Principal Investigator

Central Hospital, Nancy, France

Eligibility Criteria

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

Outcomes

Primary Outcomes

Visual acuity measurement

Time Frame: 7 years post-natal age

Parinaud and Snellen tests

Secondary Outcomes

  • Measurement of cyclopegic refraction(7 years of age)

Study Sites (1)

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