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

April 30, 2025 updated by: Intelon Optics, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
        • Vold Vision plc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Biomechanical Imaging of the Eye
Diagnostic test: BOSS Imaging
Biomechanical Imaging of Cornea and Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intelon Optics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2022

Primary Completion (Actual)

September 13, 2022

Study Completion (Actual)

September 13, 2022

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • P22-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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