Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases
1 other identifier
observational
114
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedFirst Submitted
Initial submission to the registry
February 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedFebruary 20, 2018
February 1, 2018
4 months
February 12, 2018
February 18, 2018
Conditions
Outcome Measures
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.
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 Outcomes (1)
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.
Study Arms (2)
Normal group
Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT)
Retinal diseases group
Patients with various macular diseases Repeat exams of OCT device (SD and SS-OCT)
Interventions
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
Eligibility Criteria
normal control : 36 eyes of 36 subjects retinal disease group: 78 eyes of 78 patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Study Officials
- STUDY CHAIR
Mincheol Seong, MD, PhD
Hanyang University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
February 12, 2018
First Posted
February 20, 2018
Study Start
October 1, 2017
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
February 20, 2018
Record last verified: 2018-02