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Completed

NCT Number: NCT03438903

Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases

Comparison of intradevice repeatability of thickness measurements for macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT

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Key information

Conditions

Macula Abnormality

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

About this study

The investigators studied the intradevice repeatability of thickness measurements for total retina, retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform (GC-IPL) layers of macular area in the eyes with normal and various retinal diseases using SS-OCT and SD-OCT and compared the repeatability between two devices.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age-matched normal group was composed of subjects with age over at least 19 years,
  • a best-corrected visual acuity of 20/25 or higher,
  • normal fundus and intraocular pressure (IOP) < 21mm Hg.

Exclusion criteria

  • an spherical equivalent (SE) larger than ± 6 D,
  • cataract graded as more severe than grade 3 (Lens Opacities Classification System III),
  • a history of glaucoma and optic nerve diseases, or a history of vitrectomy.

Treatment and study plan

Repeat exams of OCT device

Device

All 2 consecutive OCT examinations were performed by 1 experienced technician, in the order of SD-OCT and SS-OCT. The interval was 10 minutes between examinations by each OCT devices

Primary outcomes

  1. To compare repeatability between swept-source optical coherence tomography (SS-OCT) and spectral-domain OCT (SD-OCT) devices for the measurement of retinal thickness in various retinal diseases.

    Time frame: Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.

    Comparison of Intraclass correlation coefficient (ICC) and coefficients of variability (CV) between devices

Secondary outcomes

  1. To compare repeatability according to the degree of macular thickness

    Time frame: Each device was examined twice consecutively within one minutes. After one OCT device exam, another OCT exam was performed immediately. The interval between test devices did not exceed 5 minutes.

    To compare the repeatability of retinal thickness according to central macular thickness in eyes with retinal diseases

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Official study title

Comparison of Repeatability Between Swept-source and Spectral-domain Optical Coherence Tomography for Measuring Inner Retinal Thickness in Various Retinal Diseases

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
Feb 20, 2018

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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