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TerminatedNCT03207477PrmvsionSuivUpdated Aug 13, 2021

Premavision Cohort Follow-up

An interventional study of Visual acuity measurement in Visual Disorder, sponsored by Central Hospital, Nancy, France. Terminated at 1 site in France. Open to participants aged 18 Months to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-13.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Screening

Why this study was terminated
Principal Investigator not available anymore (Sabbatical)
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Months to 7 Years
Sex
All
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Study 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.

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Conditions studied

  • Visual Disorder

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Keywords

  • Infant
  • Prematurely born
  • maturation
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In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's enrollment of 37 is below the median of 66 across 211 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Months to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Infants included in the Premavision cohort
  • Term born healthy control infants at matched postnatal age

Exclusion criteria

Exclusion Criteria:

  • Ocular malformation
  • Genetic abnormality
  • Neurodevelopmental impairment
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Prematurely born infants

    Visual acuity measurement in prematurely born infants included in PREMAVISION study

    Diagnostic Test: Visual acuity measurement

  • Active comparator
    Term born infants

    Visual acuity measurement in term born control infants

    Diagnostic Test: Visual acuity measurement

Interventions

  • Diagnostic testVisual 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

    Also known as: Measurement of cycloplegic refraction

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What researchers measure

Primary outcomes

  1. Visual acuity measurement

    Baby Vision Cards

    Time frame: 18 months corrected age

  2. Visual acuity measurement

    Rossano Weiss test

    Time frame: 4 years post-natal age

  3. Visual acuity measurement

    Parinaud and Snellen tests

    Time frame: 7 years post-natal age

Secondary outcomes

  1. Measurement of cyclopegic refraction

    Non invasive refraction measurement by autorefractometer Cycloplégie par Skiacol

    Time frame: 18 months corrected age

  2. Measurement of cyclopegic refraction

    Non invasive refraction measurement by autorefractometer

    Time frame: 4 years of age

  3. Measurement of cyclopegic refraction

    Non invasive refraction measurement by autorefractometer

    Time frame: 7 years of age

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Study locations

1 site
  • Maternity Hospital CHRU
    Nancy, 54035, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03207477
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Jean-Michel HASCOET (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Jul 2, 2017
Start date
Nov 20, 2017
Primary completion
Jun 30, 2020
Completion
Jun 30, 2021
Last update
Aug 13, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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