- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03207477
Premavision Cohort Follow-up (PrmvsionSuiv)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nancy, France, 54035
- Maternity Hospital CHRU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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:
|
Active Comparator: Term born infants
Visual acuity measurement in term born control infants
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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