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

Intelon Optics

Status: Completed

Conditions: Healthy Eyes; Corneal Transplant; Corneal Crosslinking

Treatments: Diagnostic Test: BOSS Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT05423041

P22-01

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 1 patient group

Biomechanical Imaging of the Eye

Other group

Treatment:

Diagnostic Test: BOSS Imaging