NCT05423041

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Intelon Optics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Corneal Transplant
• Corneal Crosslinking
• Healthy Eyes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BOSS Imaging	Biomechanical Imaging of Cornea and Lens

Timeline

• Start date: 2022-05-14
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2022-06-21
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study