A Prospective Trial of the Intelon BOSS(TM) System

Intelon Optics

Status: Terminated

Conditions: Lens Diseases; Cornea

Treatments: Other: Brillouin Spectroscopy via BOSS System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04969406

P21-02

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Imaging by BOSS System

Experimental group

Description:

Imaging by the BOSS System

Treatment:

Other: Brillouin Spectroscopy via BOSS System