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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065072
• Other study ID #: Tomey OA-2000-001
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: September 2023
• Source: Tomey Corporation
• Contact: Deep Soni
• Phone: 857-250-9178
• Email: deep[@]neeraeye.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 167
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria - Normal Cohort:

1. Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;

2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

3. Subjects who agree to participate in the study.

Inclusion Criteria - Cataract Cohort:

1. Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;

2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

3. Subjects who agree to participate in the study;

4. Subjects diagnosed with cataract classified per the LOCS III scale.

Inclusion Criteria - Special Eyes Cohort (eyes without a natural lens or eyes containing artificial materials):

1. Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;

2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

3. Subjects who agree to participate in the study;

4. Subjects diagnosed with one or both eyes having aphakia, pseudophakia or silicone oil.

Exclusion Criteria - Normal Cohort:

1. Subjects unable to tolerate ophthalmic imaging;

2. Subjects who did not take off their contact lenses earlier than 15 minutes prior to the study;

3. Subjects with any current ocular pathology, as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;

4. Subjects that present with an active ocular infection in either eye;

5. Subjects who have a history of ocular surgery, including laser therapy/surgery;

6. Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Exclusion Criteria - Cataract Cohort:

1. Subjects unable to tolerate ophthalmic imaging;

2. Subjects who did not take off their contact lenses earlier than 15 minutes prior to the study;

3. Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;

4. Subjects that present with an active ocular infection in either eye;

5. Subjects who have a history of ocular surgery, including laser therapy/surgery;

6. Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Exclusion Criteria - Special Eyes Cohort (eyes without a natural lens or eyes containing artificial materials):

1. Subjects unable to tolerate ophthalmic imaging;

2. Subjects who did not take off their contact lenses earlier than 15 minutes prior to the study;

3. Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;

4. Subjects that present with an active ocular infection in either eye;

5. Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;

6. Subjects with evidence of silicone oil emulsification;

7. Subjects with silicone oil in the anterior chamber;

8. Subjects with adherence of oil droplets to an intraocular lens.

Related Conditions & MeSH terms

• Aphakia
• Aphakic Eye
• Cataract
• Pseudophakia

Intervention

Device:
• Optical measurement
Optical measurements by optical biometers and an OCT

Locations

Country	Name	City	State
United States	NorthEast Eye Research Associates	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tomey Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between the test devices and predicate device	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.	Through study completion, approximately 4 months
Primary	Precision of the test devices	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.	Through study completion, approximately 4 months
Primary	Safety of the test devices	Adverse events reported will be listed by subject.	Through study completion, approximately 4 months