NCT06065072

Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 167 (estimated)
• Sponsor: Tomey Corporation · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This is a prospective comparative study that will be conducted at one clinical site in the United States, in which subjects who sign an informed consent form and fulfil all inclusion and exclusion criteria, will have OCT scans obtained using the test and the predicate devices. There will be two main types of analyses performed as part of this study, including 1) a precision analysis, and 2) an agreement analysis. The precision analyses will be conducted utilizing all complete complements of acceptable scans from the test devices and predicate device for each of the 3 configurations. A complete complement of acceptable scans can be defined as subjects having 3 acceptable replicate scans on each of the 3 devices, at each of the 3 configurations. This is also synonymous with 3 scans for each of the 3 configurations on all 3 devices. If subjects have more than 3 acceptable scans per configuration on a device, only the first 3 will be considered for analyses. The agreement analysis will be conducted utilizing the first set of acceptable scans from each instrument for all overlapping measurement types (for all measurement types two or more of the devices have in common) related to performance endpoints.

Conditions

• Cataract
• Aphakic Eye
• Pseudophakia

Interventions

Type	Name	Description
DEVICE	Optical measurement	Optical measurements by optical biometers and an OCT

Timeline

• Start date: 2023-06-23
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2023-10-03
• Last updated: 2023-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study