NCT02466932

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

June 3, 2015

Last Update Submit

June 4, 2015

Conditions

Birth Weight

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Birth Weight

Device: Galilei Dual-Scheimpflug Analyzer

Interventions

Galilei Dual-Scheimpflug AnalyzerDEVICE

Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer

Birth Weight

Eligibility Criteria

Age30 Months - 80 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Birth Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 9, 2015

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 9, 2015

Record last verified: 2015-06