A Prospective Trial of the Intelon BOSS(TM) System

NCT ID: NCT04969406

Last Updated: 2022-06-10

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

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-24

Study Completion Date

2021-12-10

Brief Summary

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A prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the BOSS device. Subjects will undergo unilateral biomechanical mapping of the cornea and lens by three BOSS devices operated by three (3) different operators.

Detailed Description

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Conditions

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Cornea Lens Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Imaging by BOSS System

Imaging by the BOSS System

Group Type EXPERIMENTAL

Brillouin Spectroscopy via BOSS System

Intervention Type OTHER

Biomechanical Imaging of the Cornea and Lens

Interventions

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Brillouin Spectroscopy via BOSS System

Biomechanical Imaging of the Cornea and Lens

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older
2. Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
3. Signed Written Informed Consent

Exclusion Criteria

1. No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
2. Presence of corneal opacity
3. Presence of cortical cataracts visible in an undilated pupil
4. Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Intelon Optics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vold Vision plc

Fayetteville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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P21-02

Identifier Type: -

Identifier Source: org_study_id

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