Eye ColorNCT03072368
Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
A study testing Photograph in people with Eye Color, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns. Read more about this study
- Who is it for?
- Ages 2 days to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Eye Color
- What is being tested?
- Photograph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2017to 1 Apr 2018
- 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 2 days to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any baby born between the 24-42 week of gestation admitted to the well-baby nursery or the NICU whose parents have signed an informed consent.
Who cannot join
- Neonatal conjunctivitis
- Neonatal sepsis
- Inborn error of metabolism or genetic syndrome
- Eye abnormalities
- Parental refusal
Trial locations and contacts
1 site in 1 country.
Amit Hochberg, MD contact
About this study
The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns.
- Conditions
- Eye Color
- Being tested
- Photograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotographOther
Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age
| Study group | Role | What they receive |
|---|---|---|
| Blue eyes | Active comparator | 50 babies born with blue eyes will be photographed and followed-up at baseline; 3 months and 12 months of age Receives: Other: Photograph |
| Brown eyes | Active comparator | 50 babies born with brown eyes will be photographed and followed-up at baseline; 3 months and 12 months of age Receives: Other: Photograph |
| Green eyes | Active comparator | 50 babies born with green eyes will be photographed and followed-up at baseline; 3 months and 12 months of age Receives: Other: Photograph |
| Hazel eyes | Active comparator | 50 babies born with hazel eyes will be photographed and followed-up at baseline; 3 months and 12 months of age Receives: Other: Photograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eye color
Change will be measured according to a validated classification of blue/hazel/green or brown
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startMar 2017 (estimated)
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye ColorStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amit Hochberg, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072368
- Sponsor's protocol ID
- HYMC-0081-16
- Status last verified
- Feb 2017
- First submitted
- 27 Feb 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics
- ClinicalTrials.gov ID
- NCT03072368
- Acronym / sponsor ID
- HYMC-0081-16
- Conditions
- Eye Color
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2017 (estimated)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 7 Mar 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.
The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blue eyes | Active comparator | Other: Photograph50 babies born with blue eyes will be photographed and followed-up at baseline; 3 months and 12 months of age |
| Brown eyes | Active comparator | Other: Photograph50 babies born with brown eyes will be photographed and followed-up at baseline; 3 months and 12 months of age |
| Green eyes | Active comparator | Other: Photograph50 babies born with green eyes will be photographed and followed-up at baseline; 3 months and 12 months of age |
| Hazel eyes | Active comparator | Other: Photograph50 babies born with hazel eyes will be photographed and followed-up at baseline; 3 months and 12 months of age |
Who may qualify
- Ages
- 2 days to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any baby born between the 24-42 week of gestation admitted to the well-baby nursery or the NICU whose parents have signed an informed consent.
Key exclusion criteria (5 listed)
- Neonatal conjunctivitis
- Neonatal sepsis
- Inborn error of metabolism or genetic syndrome
- Eye abnormalities
- Parental refusal
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 |
|---|---|---|
| PhotographBabies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age | Other | Blue eyes, Brown eyes, Green eyes, Hazel eyes |
Primary outcome
Change in eye color
Time frame: One year
Change will be measured according to a validated classification of blue/hazel/green or brown
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- 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.
Amit Hochberg, MD contact
Amit Hochberg, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photograph in people with Eye Color, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Mar 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit Hochberg, MD (amith@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eye color (time frame: One year). 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 7 Mar 2017.