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

Intelon Optics, Inc34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Corneal Transplant Corneal Crosslinking Healthy Eyes

Interventions

BOSS ImagingDIAGNOSTIC_TEST

Biomechanical Imaging of Cornea and Lens

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older Exclusion Criteria: * No light perception * Any systemic disease or disorder which would prohibit image aquisition

Locations (1)

Vold Vision plc

Fayetteville, Arkansas, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days

Data from ClinicalTrials.gov

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