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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438903
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yong Un shin, Hanyang University

Tracking Information
First Submitted Date February 12, 2018
First Posted Date February 20, 2018
Last Update Posted Date February 20, 2018
Actual Study Start Date October 1, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 18, 2018)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Repeatability Between SS and SD-OCT for Measuring Retinal Thickness in Various Retinal Diseases
Official Title Comparison of Repeatability Between Swept-source and Spectral-domain Optical Coherence Tomography for Measuring Inner Retinal Thickness in Various Retinal Diseases
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

normal control : 36 eyes of 36 subjects

retinal disease group: 78 eyes of 78 patients

Condition Macula Abnormality
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
Study Groups/Cohorts
  • Normal group
    Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT)
    Intervention: Device: Repeat exams of OCT device
  • Retinal diseases group
    Patients with various macular diseases Repeat exams of OCT device (SD and SS-OCT)
    Intervention: Device: Repeat exams of OCT device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2018)
114
Original Actual Enrollment Same as current
Actual Study Completion Date January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03438903
Other Study ID Numbers 2017-10-013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Yong Un shin, Hanyang University
Study Sponsor Hanyang University
Collaborators Not Provided
Investigators
Study Chair: Mincheol Seong, MD, PhD Hanyang University
PRS Account Hanyang University
Verification Date February 2018