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

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.

Completed

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Key information

Conditions

Corneal Transplant Corneal Crosslinking Healthy Eyes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vold Vision plc

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older

Exclusion criteria

No light perception
Any systemic disease or disorder which would prohibit image aquisition

Treatment and study plan

BOSS Imaging

Diagnostic Test

Biomechanical Imaging of Cornea and Lens

Primary outcomes

Analysis of variance in BOSS analysis to determine repeatability and reproducibility

Time frame: 30 days

A random effect model will be used to assess variation due to device/operator configuration

Sponsors and collaborators

Lead sponsor

Intelon Optics, Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 21, 2022
Registry last updated: May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed