Study of the Choroidal and Retinal Thickness in Relation to Axial Length. (CHORAL)

Study of the Choroidal and Retinal Thickness in Relation to Axial Length in Healthy Young Subjects With Swept-source Optical Coherence Tomography.

The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: AL measurement; Device: OCT

Detailed Description

The choroid is responsible for the oxygen supply of the outer retina, hence many diseases that affect the retina are originating from the choroid or at later stages influence the choroid as well. The functional efficiency of the choroid in a healthy subject is important. The thickness of the choroid is a marker for the extent of the vessels inside.

With optical coherence tomography (OCT) non-invasive and non-contact measurement of the choroidal and retinal thickness is possible. Swept-source OCT is one the latest developments of OCTs. Its increase wavelength allows deeper penetration than previous models and allows high resolution imaging.

OCTs are FDA approved machines, they are not considered experimental. The swept-source OCT machine (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan) used in the study is a CE marked commercially available medical device.

The goal of the study is to evaluate the choroidal and the retinal morphology in relation to the length of the eyeball (axial length - AL) in healthy, young adults.

There are several publications on this topic, most of them on asian populations.

In the study healthy, Caucasians in their twenties are recruited to minimize the aging effect on choroidal thickness.

Following informed consent, demographics are recorded, refraction is taken, axial length is measured with IOL Master 500 (Carl Zeiss AG, Germany) then OCT is performed.

Pupil dilation is not necessary. Images are stored digitally by abiding corresponding laws on personal data protection. Results are processed with statistical analysis.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis University, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy subject with no eye diseases.

Description

Inclusion Criteria:

• 18 years of age or older, but less than 29 years of age
• Caucasian race
• Signed informed consent

Exclusion Criteria:

• Known epilepsy
• Inability to act
• Media opacity in the eye that would disturb imaging

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	Device: AL measurement; IOL Master 500 (Carl Zeiss AG, Germany); Device: OCT; Choroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relation of choroidal thickness to axial length	Through study completion, 6 months
Relation of retinal thickness to axial length	Through study completion, 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Influence of age on results	Through study completion, 6 months
Influence of gender on results	Through study completion, 6 months

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Miklos Schneider, Semmelweis University, Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): October 3, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CHORAL-1249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No