- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02466932
Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
June 4, 2015 updated by: Volkan YETER, Neon Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
78
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 months to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy children aged between 3-6- preschoolers- born at term and have birth weight heavier than 2500g
Description
Inclusion Criteria:
- 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;
- no retinopathy of prematurity;
- no current medications; and
- no retinal or optic disc abnormalities on fundoscopy.
Exclusion Criteria:
- 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;
- retinopathy of prematurity;
- current medications; and
- retinal or optic disc abnormalities on fundoscopy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Birth Weight
|
Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
June 4, 2015
First Posted (Estimate)
June 9, 2015
Study Record Updates
Last Update Posted (Estimate)
June 9, 2015
Last Update Submitted That Met QC Criteria
June 4, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-171
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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