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

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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

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

Condition or disease Intervention/treatment
Macula Abnormality Device: Repeat exams of OCT device

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.

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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Repeatability Between Swept-source and Spectral-domain Optical Coherence Tomography for Measuring Inner Retinal Thickness in Various Retinal Diseases
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal group
Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT)
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

Retinal diseases group
Patients with various macular diseases Repeat exams of OCT device (SD and SS-OCT)
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




Primary Outcome Measures :
  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. [ 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

normal control : 36 eyes of 36 subjects

retinal disease group: 78 eyes of 78 patients

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438903


Locations
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Korea, Republic of
Hanyang University Guri Hospital
Guri-si,, Gyeonggi-do, Korea, Republic of, 11923
Sponsors and Collaborators
Hanyang University
Investigators
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Study Chair: Mincheol Seong, MD, PhD Hanyang University
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Responsible Party: Yong Un shin, Assistant professor, Hanyang University
ClinicalTrials.gov Identifier: NCT03438903    
Other Study ID Numbers: 2017-10-013
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases