Premavision Cohort Follow-up

NCT ID: NCT03207477

Last Updated: 2021-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2021-06-30

Brief Summary

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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

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Conditions

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Visual Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Longitudinal cohort study with a control group
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Prematurely born infants

Visual acuity measurement in prematurely born infants included in PREMAVISION study

Group Type EXPERIMENTAL

Visual acuity measurement

Intervention Type DIAGNOSTIC_TEST

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

Term born infants

Visual acuity measurement in term born control infants

Group Type ACTIVE_COMPARATOR

Visual acuity measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Measurement of cycloplegic refraction

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel HASCOET

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternity Hospital CHRU

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2016-A02017-44

Identifier Type: -

Identifier Source: org_study_id

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