Evaluation of the Signal to Noise Ratio at Various Retinal Layers

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)

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

Study Overview

• Status: Completed
• Conditions: Healthy Eyes
• Intervention / Treatment: Device: 3D OCT-1 Maestro; Device: DRI OCT Triton

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Oakland, New Jersey, United States, 07436
      • Topcon Medical Systems Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30 subjects willing to participate in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Eyes; Subjects with no known ocular diseases will be imaged on the 3D OCT-1 Maestro and DRI OCT Triton	Device: 3D OCT-1 Maestro; Image acquisition of the posterior surface of the eye; Device: DRI OCT Triton; Image acquisition of the posterior surface of the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Signal to noise ratio between SD OCT and SS OCT	5 minutes

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: no known ocular pathology
• Other Study ID Numbers: Topcon-601-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO