CompletedNot Applicable

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

United States34 participantsStarted 2022-05-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Analysis of variance in BOSS analysis to determine repeatability and reproducibility

Timeframe: 30 days

Trial details

NCT IDNCT05423041

SponsorIntelon Optics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-13

View on ClinicalTrials.gov More Corneal Transplant trials