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

Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466932
• Other study ID #: 2010-171
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: June 4, 2015
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: Neon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 80 Months

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Birth Weight

Intervention

Device:
• Galilei Dual-Scheimpflug Analyzer
Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Neon Hospital	Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	Yes