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

Recruiting

• Conditions: Cataract; Aphakic Eye; Pseudophakia
• Interventions: Device: Optical measurement

• Registration Number: NCT06065072
• Lead Sponsor: Tomey Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-23
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-26
• Last Update Submitted: 2023-09-26
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cataract	Optical measurement	-
Special eye	Optical measurement	-
Normal	Optical measurement	-

Primary Outcome Measures

Name	Time	Method
Agreement between the test devices and predicate device	Through study completion, approximately 4 months	Agreement between each of the test devices and the predicate device will be evaluated by the mean difference and SD, the 95% limits of agreement (LOA), the Bland-Altman plots, and Deming regression for each subject population.
Precision of the test devices	Through study completion, approximately 4 months	A crossed two-way random-effects analysis of variance (ANOVA) model will be used to estimate the repeatability and reproducibility limits of each scan parameter by subject population and study device (test and predicate device). This ANOVA model will include the configuration, subject, and interaction between configuration and subject as the factors. Repeatability and reproducibility standard deviations, as well as the corresponding coefficient of variations (CVs), will be calculated using this ANOVA model.
Safety of the test devices	Through study completion, approximately 4 months	Adverse events reported will be listed by subject.

Trial Locations

Locations (1)

NorthEast Eye Research Associates; 🇺🇸 Woburn, Massachusetts, United States