NCT04969406

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 24, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

June 10, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

July 7, 2021

Last Update Submit

June 8, 2022

Conditions

CorneaLens Diseases

Outcome Measures

Primary Outcomes (1)

  • Analysis of variance in corneal and lens measurements to determine repeatability and reproducibility

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

    Evaluation Visit (within 30 days of the Screening Visit)

Study Arms (1)

Imaging by BOSS System

EXPERIMENTAL

Imaging by the BOSS System

Other: Brillouin Spectroscopy via BOSS System

Interventions

Brillouin Spectroscopy via BOSS SystemOTHER

Biomechanical Imaging of the Cornea and Lens

Imaging by BOSS System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule
  • Signed Written Informed Consent

You may not qualify if:

  • No light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images
  • Presence of corneal opacity
  • Presence of cortical cataracts visible in an undilated pupil
  • Any systemic disease or disorder which would prohibit image acquisition (e.g., Parkinson's Disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vold Vision plc

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Corneal DiseasesLens Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 20, 2021

Study Start

July 24, 2021

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

June 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)