Visual DisorderPrmvsionSuivNCT03207477
Premavision Cohort Follow-up
A study testing Visual acuity measurement in people with Visual Disorder, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Disorder
- What is being tested?
- Visual acuity measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants included in the Premavision cohort
- Term born healthy control infants at matched postnatal age
Who cannot join
- Ocular malformation
- Genetic abnormality
- Neurodevelopmental impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Visual Disorder
- Being tested
- Visual acuity measurement
- Keywords
- Infant, Prematurely born, maturation
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual acuity measurementDiagnostic test
Also called Measurement of cycloplegic refraction
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
| Study group | Role | What they receive |
|---|---|---|
| Prematurely born infants | Experimental | Visual acuity measurement in prematurely born infants included in PREMAVISION study Receives: Diagnostic Test: Visual acuity measurement |
| Term born infants | Active comparator | Visual acuity measurement in term born control infants Receives: Diagnostic Test: Visual acuity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity measurement
Baby Vision Cards
Measured: 18 months corrected age
Visual acuity measurement
Rossano Weiss test
Measured: 4 years post-natal age
Visual acuity measurement
Parinaud and Snellen tests
Measured: 7 years post-natal age
Secondary outcomes (3)
Measurement of cyclopegic refraction
Non invasive refraction measurement by autorefractometer Cycloplégie par Skiacol
Measured: 18 months corrected age
Measurement of cyclopegic refraction
Non invasive refraction measurement by autorefractometer
Measured: 4 years of age
Measurement of cyclopegic refraction
Non invasive refraction measurement by autorefractometer
Measured: 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start20 Nov 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Why it stopped: Principal Investigator not available anymore (Sabbatical)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Longitudinal cohort study with a control group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207477
- Sponsor's protocol ID
- 2016-A02017-44
- Acronym
- PrmvsionSuiv
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2017
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03207477
- Acronym / sponsor ID
- PrmvsionSuiv / 2016-A02017-44
- Conditions
- Visual Disorder
- Keywords
- Infant, Prematurely born, maturation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator not available anymore (Sabbatical)
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal cohort study with a control group
| Arm | Type | Receives |
|---|---|---|
| Prematurely born infants | Experimental | Diagnostic Test: Visual acuity measurementVisual acuity measurement in prematurely born infants included in PREMAVISION study |
| Term born infants | Active comparator | Diagnostic Test: Visual acuity measurementVisual acuity measurement in term born control infants |
Who may qualify
- Ages
- 18 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants included in the Premavision cohort
- Term born healthy control infants at matched postnatal age
Key exclusion criteria (3 listed)
- Ocular malformation
- Genetic abnormality
- Neurodevelopmental impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual acuity measurementAlso: Measurement of cycloplegic refractionvisual 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 | Diagnostic test | Prematurely born infants, Term born infants |
Primary outcome
Visual acuity measurement
Time frame: 18 months corrected age
Baby Vision Cards
Visual acuity measurement
Time frame: 4 years post-natal age
Rossano Weiss test
Visual acuity measurement
Time frame: 7 years post-natal age
Parinaud and Snellen tests
3 secondary outcomes
Measurement of cyclopegic refraction
Time frame: 18 months corrected age
Measurement of cyclopegic refraction
Time frame: 4 years of age
Measurement of cyclopegic refraction
Time frame: 7 years of age
Results and safety
The study was stopped early (reason given: Principal Investigator not available anymore (Sabbatical)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual acuity measurement in people with Visual Disorder, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator not available anymore (Sabbatical)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity measurement (time frame: 18 months corrected age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.