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NCT02982174 Clinical Trial

Evaluation of the Signal to Noise Ratio at Various Retinal Layers

Healthy Eyes Clinical Trial

Official title:
Evaluation of the Signal to Noise Ratio at Various Retinal Layers in Spectral Domain Optical Coherence Tomography (SD OCT) Compared to Swept Source Optical Coherence Tomography (SS OCT)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02982174
Other study ID # Topcon-601-2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2016
Est. completion date January 2017

Study information
Verified date June 2022
Source Topcon Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Compare the signal to noise ratio of each device at various retinal layers.

Description:

Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal layers from the same group of subjects

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female patients > 18 years old who have full legal capacity to volunteer on the date the informed consent is signed. 2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. 3. Subjects who agree to participate in the study. Exclusion Criteria: 1. History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. 2. Fixation problems which may prevent obtaining good quality images in either eye.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 3D OCT-1 Maestro
Image acquisition of the posterior surface of the eye
• DRI OCT Triton
Image acquisition of the posterior surface of the eye

Locations
Country Name City State
United States Topcon Medical Systems Inc. Oakland New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Signal to noise ratio between SD OCT and SS OCT 5 minutes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06071546 - Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology N/A
Completed NCT03080714 - Triton Agreement and Precision Study
Completed NCT03067675 - Triton Reference Database
Completed NCT03022383 - TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus
Withdrawn NCT02991027 - OCT Image Quality Performance Evaluation N/A
Active, not recruiting NCT04661124 - Evaluation of the Heidelberg Engineering SPECTRALIS With Flex Module for In-vivo Imaging in the Supine Position