P200TxE Diseased Eye Image Collection

NCT ID: NCT06269666

Last Updated: 2024-09-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-12-01

Brief Summary

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The primary objective is to collect images on the P200TxE device in diseased eyes.

Detailed Description

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Conditions

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Retinal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Imaging Session

Various scans will be captured

Group Type OTHER

P200TxE

Intervention Type DEVICE

SLO and OCT imaging

Interventions

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P200TxE

SLO and OCT imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects 22 years of age or older who have full legal capacity to subject on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site;
3. Subjects who agree to participate;
4. Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve.

For glaucoma subjects:

a. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable images.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Optos, PLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bennett and Bloom Eye Centers

Louisville, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Megan Kingdon

Role: primary

513-305-8654

Other Identifiers

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OPT1100

Identifier Type: -

Identifier Source: org_study_id

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