Non-Invasive Imaging of the Human Eye

Withdrawn

• Conditions: Willing and Able Subjects for Ocular Imaging
• Interventions: Device: 3D OCT-1; Device: 3D OCT-2000; Device: DRI OCT-1; Device: NW-300; Device: CT-1P; Device: TRK-2P; Device: SP-1P; Device: SL-D701; Device: MC-4S

• Registration Number: NCT02432898
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

Evaluate the clinical information obtained from the use of the machines.

Detailed Description

Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-11-20
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female patients from 18 to 80 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.

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Exclusion Criteria

1. History of ocular pathology.
2. History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
3. History of systemic disease
4. fixation problems which may prevent obtaining good quality images in the eye.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Healthy Eyes	SL-D701	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	SP-1P	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	CT-1P	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	3D OCT-1	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	3D OCT-2000	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	DRI OCT-1	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	TRK-2P	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	MC-4S	Normal healthy eyes with no known ocular diseases
Normal Healthy Eyes	NW-300	Normal healthy eyes with no known ocular diseases

Primary Outcome Measures

Name	Time	Method
Device Evaluation	1 Hour	Determine Clinical Utility, Efficacy, and Safety

Trial Locations

Locations (1)

Topcon Medical Systems, Inc.; 🇺🇸 Oakland, New Jersey, United States