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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05423041

Enrollment

Registered

2022-06-21

Start date

2022-05-14

Completion date

2022-09-13

Last updated

2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Crosslinking, Corneal Transplant, Healthy Eyes

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.

Interventions

DIAGNOSTIC_TESTBOSS Imaging

Biomechanical Imaging of Cornea and Lens

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 18 years or older

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Analysis of variance in BOSS analysis to determine repeatability and reproducibility	30 days	A random effect model will be used to assess variation due to device/operator configuration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026