A Prospective Clinical Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(tm) System

NCT ID: NCT05423041

Last Updated: 2025-05-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-14

Study Completion Date

2022-09-13

Brief Summary

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

Detailed Description

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Conditions

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Corneal Transplant Corneal Crosslinking Healthy Eyes

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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Biomechanical Imaging of the Eye

Group Type OTHER

BOSS Imaging

Intervention Type DIAGNOSTIC_TEST

Biomechanical Imaging of Cornea and Lens

Interventions

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BOSS Imaging

Biomechanical Imaging of Cornea and Lens

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 years or older

Exclusion Criteria

* No light perception
* Any systemic disease or disorder which would prohibit image aquisition
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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P22-01

Identifier Type: -

Identifier Source: org_study_id

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