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Premavision Cohort Follow-up (PrmvsionSuiv)

Primary Purpose

Visual Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Visual acuity measurement
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Visual Disorder focused on measuring Infant, Prematurely born, maturation

Eligibility Criteria

18 Months - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maternity Hospital CHRU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prematurely born infants

Term born infants

Arm Description

Visual acuity measurement in prematurely born infants included in PREMAVISION study

Visual acuity measurement in term born control infants

Outcomes

Primary Outcome Measures

Visual acuity measurement
Baby Vision Cards
Visual acuity measurement
Rossano Weiss test
Visual acuity measurement
Parinaud and Snellen tests

Secondary Outcome Measures

Measurement of cyclopegic refraction
Non invasive refraction measurement by autorefractometer Cycloplégie par Skiacol
Measurement of cyclopegic refraction
Non invasive refraction measurement by autorefractometer
Measurement of cyclopegic refraction
Non invasive refraction measurement by autorefractometer

Full Information

First Posted
June 30, 2017
Last Updated
August 9, 2021
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03207477
Brief Title
Premavision Cohort Follow-up
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator not available anymore (Sabbatical)
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Disorder
Keywords
Infant, Prematurely born, maturation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Longitudinal cohort study with a control group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prematurely born infants
Arm Type
Experimental
Arm Description
Visual acuity measurement in prematurely born infants included in PREMAVISION study
Arm Title
Term born infants
Arm Type
Active Comparator
Arm Description
Visual acuity measurement in term born control infants
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual acuity measurement
Other Intervention Name(s)
Measurement of cycloplegic refraction
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual acuity measurement
Description
Baby Vision Cards
Time Frame
18 months corrected age
Title
Visual acuity measurement
Description
Rossano Weiss test
Time Frame
4 years post-natal age
Title
Visual acuity measurement
Description
Parinaud and Snellen tests
Time Frame
7 years post-natal age
Secondary Outcome Measure Information:
Title
Measurement of cyclopegic refraction
Description
Non invasive refraction measurement by autorefractometer Cycloplégie par Skiacol
Time Frame
18 months corrected age
Title
Measurement of cyclopegic refraction
Description
Non invasive refraction measurement by autorefractometer
Time Frame
4 years of age
Title
Measurement of cyclopegic refraction
Description
Non invasive refraction measurement by autorefractometer
Time Frame
7 years of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Maternity Hospital CHRU
City
Nancy
ZIP/Postal Code
54035
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Premavision Cohort Follow-up

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