- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03438903
Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases
February 18, 2018 updated by: Yong Un shin, Hanyang University
Comparison of Repeatability Between Swept-source and Spectral-domain Optical Coherence Tomography for Measuring Inner 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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
114
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
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Guri-si,, Gyeonggi-do, Korea, Republic of, 11923
- Hanyang University Guri Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
normal control : 36 eyes of 36 subjects
retinal disease group: 78 eyes of 78 patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal group
Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT)
|
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
|
Retinal diseases group
Patients with various macular diseases Repeat exams of OCT device (SD and SS-OCT)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mincheol Seong, MD, PhD, Hanyang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2017
Primary Completion (ACTUAL)
January 31, 2018
Study Completion (ACTUAL)
January 31, 2018
Study Registration Dates
First Submitted
February 12, 2018
First Submitted That Met QC Criteria
February 18, 2018
First Posted (ACTUAL)
February 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2018
Last Update Submitted That Met QC Criteria
February 18, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-10-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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