Premavision Cohort Follow-up

Study Overview
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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.

Official Title
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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.

Conditions
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Visual Disorder

Intervention / Treatment
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* Diagnostic Test: Visual acuity measurement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Longitudinal cohort study with a control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prematurely born infants<br>Visual acuity measurement in prematurely born infants included in PREMAVISION study | Diagnostic Test: Visual acuity measurement<br>* 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<br>* Other names: Measurement of cycloplegic refraction;|
| Active Comparator: Term born infants<br>Visual acuity measurement in term born control infants | Diagnostic Test: Visual acuity measurement<br>* 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<br>* Other names: Measurement of cycloplegic refraction;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Prematurely born, maturation