Delayed Visual MaturationDVMNCT04251338
Delayed Visual Maturation: Outcome and Predictive Factors
An observational study of Delayed Visual Maturation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Delayed Visual Maturation
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Sep 2019to 10 Feb 2020
- Phase
- Observational
- 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients seen in UZ Leuven between 1998 and 2016 with diagnosis of delayed visual maturation who meet the inclusion criteria.
Who may be able to join
- Infants (male or female) with suboptimal/absent visual contact at the age of ≥3 months, without other known general developmental delay at the time diagnosis of delayed visual contact and without anatomic ocular abnormalities at the initial ophthalmological examination.
Who cannot join
- Children with known underlying psychomotor developmental delay or epilepsy at first ophthalmic consultation.
- Children with ophthalmic (anatomical) abnormalities that explain delayed visual maturation.
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation.
Read the detailed description
description of the developmental outcome of children with delayed visual maturation.
- Conditions
- Delayed Visual Maturation
- Keywords
- delayed visual maturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| delayed visual maturation | children with delayed visual maturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed visual maturation.
the prevalence of developmental problems in children with delayed visual maturation.
Measured: 1998-2016
Secondary outcomes (4)
Level of development
by questionnaire:type of education/school , problems with writing, mathematics: yes or no
Measured: 1998-2016
Fine and gross motor skills
by questionnaire: physiotherapy needed yes or no
Measured: 1998-2016
ophthalmological problems
by questionnaire : visual problems, wearing glasses? taped eyes?
Measured: 1998-2016
Visual acuity
assested at the last consultation indicated in Snellen
Measured: 1998-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start3 Sep 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Visual MaturationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingele Casteels, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251338
- Sponsor's protocol ID
- S62961
- Acronym
- DVM
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 8 May 2020
- 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 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Visual Maturation: Outcome and Predictive Factors
- ClinicalTrials.gov ID
- NCT04251338
- Acronym / sponsor ID
- DVM / S62961
- Conditions
- Delayed Visual Maturation
- Keywords
- delayed visual maturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 31 Jan 2020 (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.
The objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation.
Detailed description
description of the developmental outcome of children with delayed visual maturation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| delayed visual maturation | – | –children with delayed visual maturation |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients seen in UZ Leuven between 1998 and 2016 with diagnosis of delayed visual maturation who meet the inclusion criteria.
Key inclusion criteria (1 listed)
- Infants (male or female) with suboptimal/absent visual contact at the age of ≥3 months, without other known general developmental delay at the time diagnosis of delayed visual contact and without anatomic ocular abnormalities at the initial ophthalmological examination.
Key exclusion criteria (2 listed)
- Children with known underlying psychomotor developmental delay or epilepsy at first ophthalmic consultation.
- Children with ophthalmic (anatomical) abnormalities that explain delayed visual maturation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
delayed visual maturation.
Time frame: 1998-2016
the prevalence of developmental problems in children with delayed visual maturation.
4 secondary outcomes
Level of development
Time frame: 1998-2016
Fine and gross motor skills
Time frame: 1998-2016
ophthalmological problems
Time frame: 1998-2016
Visual acuity
Time frame: 1998-2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- 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.
Ingele Casteels, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Visual Maturation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 May 2020. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
delayed visual maturation. (time frame: 1998-2016). 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 8 May 2020.