Child, OnlyREDICNCT04827511
Refractive Disorders and Seric Vitamin D Level in Children With Disabilities
An observational study of Child, Only, run by Holhos Larisa Bianca at 1 site in Romania.
Trial summary
The investigator want to determine the refractive status of 80 children with disabilities and of 81 healthy children from a witness group. The vitamin D level of the children will be dosed for making different correlations with visual acuity status. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only
- What is being tested?
- Refraction measurement with auto-ref-keratometer Canon
- How many people
- 161 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2019to 31 Mar 2021
- How long will I take part?
- 19 Months
- 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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 80 children with disabilities like ADHD, autism, Down syndrome, deafness, phocomelia and 81 clinically healthy children
Who may be able to join
- children with disabilities and healthy children
Who cannot join
- children diagnosed with another chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
The investigator want to determine the refractive status of 80 children with disabilities and of 81 healthy children from a witness group. The vitamin D level of the children will be dosed for making different correlations with visual acuity status.
Read the detailed description
Refraction measurement will be done by the investigator in all 161 children. Visual acuity is checked, initial and after correction with proper correction. Vitamin D level is dosed from all the children in order to make correlations with the visual acuity, refractive status and risk for visual impairment.
- Conditions
- Child, Only
- Being tested
- Refraction measurement with auto-ref-keratometer Canon
- Keywords
- disability, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refraction measurement with auto-ref-keratometer CanonOther
Refractive measurement and vitamin D level dosing
| Study group | Role | What they receive |
|---|---|---|
| cohort group | 80 children with disabilities like autism, ADHD, Down syndrome, deafness, phocomelia, dyslexia, different motor problems Receives: Other: Refraction measurement with auto-ref-keratometer Canon | |
| control group | 81 healthy children, not known or diagnosed with a chronic disease of any kind Receives: Other: Refraction measurement with auto-ref-keratometer Canon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive disorders in children with disabilities
Prevalence of refractive disorders in children with disabilities
Measured: 1 January 2019-31 August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2019
- Primary completion31 Aug 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
- Target duration
- 19 Months
Sponsor and investigators
- Lead sponsor
- Holhos Larisa Bianca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Holhos Larisa Bianca, Elisantes Teola SRL
- Investigators
- Holhoș L Bianca, Doctor, Principal investigator, Faculty of Medicine and Pharmacy Oradea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827511
- Sponsor's protocol ID
- 142312202069
- Acronym
- REDIC
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reports from the statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Disorders and Seric Vitamin D Level in Children With Disabilities
- ClinicalTrials.gov ID
- NCT04827511
- Acronym / sponsor ID
- REDIC / 142312202069
- Conditions
- Child, Only
- Keywords
- disability, healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Holhos Larisa BiancaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Apr 2021 (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 investigator want to determine the refractive status of 80 children with disabilities and of 81 healthy children from a witness group. The vitamin D level of the children will be dosed for making different correlations with visual acuity status.
Detailed description
Refraction measurement will be done by the investigator in all 161 children. Visual acuity is checked, initial and after correction with proper correction. Vitamin D level is dosed from all the children in order to make correlations with the visual acuity, refractive status and risk for visual impairment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 19 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort group | – | Other: Refraction measurement with auto-ref-keratometer Canon80 children with disabilities like autism, ADHD, Down syndrome, deafness, phocomelia, dyslexia, different motor problems |
| control group | – | Other: Refraction measurement with auto-ref-keratometer Canon81 healthy children, not known or diagnosed with a chronic disease of any kind |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 80 children with disabilities like ADHD, autism, Down syndrome, deafness, phocomelia and 81 clinically healthy children
Key inclusion criteria (1 listed)
- children with disabilities and healthy children
Key exclusion criteria (1 listed)
- children diagnosed with another chronic diseases
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 |
|---|---|---|
| Refraction measurement with auto-ref-keratometer CanonRefractive measurement and vitamin D level dosing | Other | cohort group, control group |
Primary outcome
Refractive disorders in children with disabilities
Time frame: 1 January 2019-31 August 2020
Prevalence of refractive disorders in children with disabilities
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 5 Apr 2021.
- Individual participant dataSharing planned: Yes. Reports from the statistical analysis
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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.
Holhoș L Bianca, Doctor principal investigator
Faculty of Medicine and Pharmacy Oradea
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 Child, Only, run by Holhos Larisa Bianca at 1 site in Romania.
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 1 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 5 Apr 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 Romania. 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?
Refractive disorders in children with disabilities (time frame: 1 January 2019-31 August 2020). 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 5 Apr 2021.