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

NCT ID: NCT03377075

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2018-11-30

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy subjects

AL measurement

Intervention Type: DEVICE

IOL Master 500 (Carl Zeiss AG, Germany)

OCT

Intervention Type: DEVICE

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

Interventions

AL measurement

IOL Master 500 (Carl Zeiss AG, Germany)

Intervention Type: DEVICE

OCT

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Miklos Schneider MD, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miklos Schneider

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University, Department of Ophthalmology

Locations

Semmelweis University, Department of Ophthalmology

Budapest, , Hungary

Countries

Hungary

Other Identifiers

CHORAL-1249

Identifier Type: -

Identifier Source: org_study_id