Premavision Cohort Follow-up (PrmvsionSuiv)

August 9, 2021 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54035
        • Maternity Hospital CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity measurement
Time Frame: 18 months corrected age
Baby Vision Cards
18 months corrected age
Visual acuity measurement
Time Frame: 4 years post-natal age
Rossano Weiss test
4 years post-natal age
Visual acuity measurement
Time Frame: 7 years post-natal age
Parinaud and Snellen tests
7 years post-natal age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of cyclopegic refraction
Time Frame: 18 months corrected age
Non invasive refraction measurement by autorefractometer Cycloplégie par Skiacol
18 months corrected age
Measurement of cyclopegic refraction
Time Frame: 4 years of age
Non invasive refraction measurement by autorefractometer
4 years of age
Measurement of cyclopegic refraction
Time Frame: 7 years of age
Non invasive refraction measurement by autorefractometer
7 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A02017-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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