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

Macula Abnormality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438903
• Other study ID #: 2017-10-013
• Status: Completed
• Phase: N/A
• First received: February 12, 2018
• Last updated: February 18, 2018
• Start date: October 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macula Abnormality
• Retinal Diseases

Intervention

Device:
• Repeat exams of OCT 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

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Guri Hospital	Guri-si,	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Comparison of Intraclass correlation coefficient (ICC) and coefficients of variability (CV) between devices	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.
Secondary	To compare repeatability according to the degree of macular thickness	To compare the repeatability of retinal thickness according to central macular thickness in eyes with 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.