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

Completed

• Conditions: Macula Abnormality
• Interventions: Device: Repeat exams of OCT device

• Registration Number: NCT03438903
• Lead Sponsor: Hanyang University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2018-02
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-18
• Last Update Submitted: 2018-02-18
• Study First Posted: 2018-02-20
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retinal diseases group	Repeat exams of OCT device	Patients with various macular diseases Repeat exams of OCT device (SD and SS-OCT)
Normal group	Repeat exams of OCT device	Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT)

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
To compare repeatability according to the degree of macular thickness	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

Trial Locations

Locations (1)

Hanyang University Guri Hospital; 🇰🇷 Guri-si,, Gyeonggi-do, Korea, Republic of