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A Prospective Trial of the Intelon BOSS(TM) System

Sponsor
Intelon Optics, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT04969406
Collaborator
(none)
23
Enrollment
1
Location
1
Arm
4.6
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Brillouin Spectroscopy via BOSS System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective Trial Designed to Evaluate the Repeatability and Reproducibility of the Intelon BOSS(TM) System
Actual Study Start Date :
Jul 24, 2021
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility [Evaluation Visit (within 30 days of the Screening Visit)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vold Vision plc Fayetteville Arkansas United States 72704

Sponsors and Collaborators

  • Intelon Optics, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Intelon Optics, Inc
ClinicalTrials.gov Identifier:
NCT04969406
Other Study ID Numbers:
  • P21-02
First Posted:
Jul 20, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lens Diseases

Study Results

No Results Posted as of Jun 10, 2022