Birth WeightNCT02466932

Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer

An observational study of Birth Weight, run by Neon Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were measured by GD-SA and relationships between all anterior segment parameters obtained by this device and birth weight were analyzed. Read more about this study

Who is it for?: Ages 30 to 80 monthsHealthy volunteers can take part
Conditions the study is for: Birth Weight
What is being tested?: Galilei Dual-Scheimpflug Analyzer
Type of treatment: Medical device
How many people: 78 participants
Where: No sites listed yet
Study dates: Jan 2011to Mar 2013
How long will I take part?: 1 Day
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 30 to 80 months
All sexes
Healthy volunteers accepted
Child

Study population: Healthy children aged between 3-6- preschoolers- born at term and have birth weight heavier than 2500g

Who may be able to join

ages 3- 6 years;
birth weight >2,500 g;
gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) >37 weeks;
visual acuity >0.8 (in decimals);
no history of any systemic or ocular diseases;
no history of previous ocular surgeries;

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no retinopathy of prematurity;
no current medications; and
no retinal or optic disc abnormalities on fundoscopy.

Who cannot join

ages <3 >6 years;
birth weight <2,500 g;
gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) <37 weeks;
visual acuity <0.8 (in decimals);
history of any systemic or ocular diseases;
history of previous ocular surgeries;

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retinopathy of prematurity;
current medications; and
retinal or optic disc abnormalities on fundoscopy.

About this study

Read the detailed description

Preschoolers, who were born heavier, had thicker cornea and lens, longer axial length, and flatter corneal curve. The thicknesses and axial curves of central cornea within 7mm may be particularly associated with BW.

Conditions: Birth Weight
Being tested: Galilei Dual-Scheimpflug Analyzer
Medical subject headings: Birth Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Galilei Dual-Scheimpflug AnalyzerDevice
Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer

Study groups in NCT02466932
Study group	Role	What they receive
Birth Weight		Not described Receives: Device: Galilei Dual-Scheimpflug Analyzer

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurements of anterior segment parameters in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
Corneal parameters, anterior chamber parameters and lens thickness were measured by Galilei Dual-Scheimpflug Analyzer in healthy preschool children.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Mar 2013

First posted9 Jun 2015 (estimated)
Study startJan 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Birth WeightStudies 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
Time perspective: Cross-sectional
Enrolment: 78 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT02466932
Sponsor's protocol ID: 2010-171
Status last verified: Jun 2015
First submitted: 3 Jun 2015
Last updated: 9 Jun 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
RecruitingObservational study
Cadmium Exposure During Pregnancy and Fetal Growth
Cadmium, Placenta
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

All Birth Weight trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
ClinicalTrials.gov ID: NCT02466932
Acronym / sponsor ID: 2010-171
Conditions: Birth Weight
Study type: Observational
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Neon HospitalUniversity, hospital or other
Collaborators: Ondokuz Mayıs University
Study start: Jan 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 9 Jun 2015 (estimated)
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.

Detailed description

Study design

Time perspective: Cross-sectional
Target follow-up: 1 Day
Number of arms: 1

Arm	Type	Receives
Birth Weight	–	Device: Galilei Dual-Scheimpflug Analyzer

Who may qualify

Ages: 30 to 80 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Healthy children aged between 3-6- preschoolers- born at term and have birth weight heavier than 2500g

Key inclusion criteria (9 listed)

ages 3- 6 years;
birth weight >2,500 g;
gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) >37 weeks;
visual acuity >0.8 (in decimals);
no history of any systemic or ocular diseases;

Key exclusion criteria (9 listed)

ages <3 >6 years;
birth weight <2,500 g;
gestational age (i.e., the period of time between the first day of the mother's last menstrual period and birth) <37 weeks;
visual acuity <0.8 (in decimals);
history of any systemic or ocular 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
Galilei Dual-Scheimpflug AnalyzerMeasuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer	Device	Birth Weight

Primary outcome

Measurements of anterior segment parameters in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
Time frame: 1 day
Corneal parameters, anterior chamber parameters and lens thickness were measured by Galilei Dual-Scheimpflug Analyzer in healthy preschool children.

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 9 Jun 2015.

Related trials for Birth Weight

RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
RecruitingObservational study
Cadmium Exposure During Pregnancy and Fetal Growth
Cadmium, Placenta
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Birth Weight, run by Neon Hospital.

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 9 inclusion and 9 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 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Measurements of anterior segment parameters in Full-Term Children by Galilei Dual-Scheimpflug Analyzer (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02466932.

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 9 Jun 2015.