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PrmvsionSuiv: Premavision Cohort Follow-up

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Terminated
CT.gov ID
NCT03207477
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
43.3
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Visual acuity measurement
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Longitudinal cohort study with a control groupLongitudinal cohort study with a control group
Masking:
None (Open Label)
Primary Purpose:
Screening
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.
Actual Study Start Date :
Nov 20, 2017
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prematurely born infants

Visual acuity measurement in prematurely born infants included in PREMAVISION study

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
Other Names:
  • Measurement of cycloplegic refraction

    		•
    Active Comparator: Term born infants

    Visual acuity measurement in term born control infants

    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
    Other Names:
  • Measurement of cycloplegic refraction

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity measurement [18 months corrected age]

      Baby Vision Cards

    2. Visual acuity measurement [4 years post-natal age]

      Rossano Weiss test

    3. Visual acuity measurement [7 years post-natal age]

      Parinaud and Snellen tests

    Secondary Outcome Measures

    1. Measurement of cyclopegic refraction [18 months corrected age]

      Non invasive refraction measurement by autorefractometer Cycloplégie par Skiacol

    2. Measurement of cyclopegic refraction [4 years of age]

      Non invasive refraction measurement by autorefractometer

    3. Measurement of cyclopegic refraction [7 years of age]

      Non invasive refraction measurement by autorefractometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Months to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maternity Hospital CHRU Nancy France 54035

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean-Michel HASCOET, Principal Investigator, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT03207477
    Other Study ID Numbers:
    • 2016-A02017-44
    First Posted:
    Jul 2, 2017
    Last Update Posted:
    Aug 13, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jean-Michel HASCOET, Principal Investigator, Central Hospital, Nancy, France
    Infant
    Prematurely born
    maturation
    Additional relevant MeSH terms:
    Vision Disorders
    Mydriatics

    Study Results

    No Results Posted as of Aug 13, 2021