A Prospective Trial of the Intelon BOSS(TM) System

Intelon Optics, Inc23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cornea Lens Diseases

Interventions

Brillouin Spectroscopy via BOSS SystemOTHER

Biomechanical Imaging of the Cornea and Lens

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Vold Vision plc

Fayetteville, Arkansas, United States

Outcomes

Primary Outcomes

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

Time frame: Evaluation Visit (within 30 days of the Screening Visit)

Data from ClinicalTrials.gov

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