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

NCT ID: NCT03438903

Last Updated: 2018-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Macula Abnormality

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal group

Healthy subjects without any ocular problems Repeat exams of OCT device (SD and SS-OCT)

Repeat exams of OCT device

Intervention Type 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)

Repeat exams of OCT device

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Yong Un shin

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mincheol Seong, MD, PhD

Role: STUDY_CHAIR

Hanyang University

Locations

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Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2017-10-013

Identifier Type: -

Identifier Source: org_study_id

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