A Prospective Trial of the Intelon BOSS(TM) System

June 8, 2022 updated by: Intelon Optics, Inc

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaging by BOSS System
Imaging by the BOSS System
Other: Brillouin Spectroscopy via BOSS System
Biomechanical Imaging of the Cornea and Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility
Time Frame: Evaluation Visit (within 30 days of the Screening Visit)
A random effect model will be used to assess variation due to device/operator configuration
Evaluation Visit (within 30 days of the Screening Visit)

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)

July 24, 2021

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

December 10, 2021

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P21-02

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

No

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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