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Completed

NCT Number: NCT03377075

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

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.

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Key information

Conditions

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University, Department of Ophthalmology

Budapest, 1085, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AL measurement

Device

IOL Master 500 (Carl Zeiss AG, Germany)

OCT

Device

Choroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan)

Primary outcomes

  1. Relation of choroidal thickness to axial length

    Time frame: Through study completion, 6 months

  2. Relation of retinal thickness to axial length

    Time frame: Through study completion, 6 months

Secondary outcomes

  1. Influence of age on results

    Time frame: Through study completion, 6 months

  2. Influence of gender on results

    Time frame: Through study completion, 6 months

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Acronym: CHORAL

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2017
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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