NCT05423041

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 14, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2022

Completed
Last Updated

May 4, 2025

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

June 8, 2022

Last Update Submit

April 30, 2025

Conditions

Corneal TransplantCorneal CrosslinkingHealthy Eyes

Outcome Measures

Primary Outcomes (1)

  • Analysis of variance in BOSS analysis to determine repeatability and reproducibility

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

    30 days

Study Arms (1)

Biomechanical Imaging of the Eye

OTHER
Diagnostic Test: BOSS Imaging

Interventions

BOSS ImagingDIAGNOSTIC_TEST

Biomechanical Imaging of Cornea and Lens

Biomechanical Imaging of the Eye

Eligibility Criteria

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

You may qualify if:

  • years or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vold Vision plc

Fayetteville, Arkansas, 72704, United States

Location

Study Design

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

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 21, 2022

Study Start

May 14, 2022

Primary Completion

September 13, 2022

Study Completion

September 13, 2022

Last Updated

May 4, 2025

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)