MedTrace Logo

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

NCT06065072 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 167

Last updated 2023-10-03

No results posted yet for this study

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

DEVICE

Optical measurement

Optical measurements by optical biometers and an OCT

Sponsors & Collaborators

  • Tomey Corporation

    lead INDUSTRY

Principal Investigators

  • Ioanis Panagiotopoulos, Dr. · NorthEast Eye Research Associates

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065072 on ClinicalTrials.gov