Recruiting

Tomey OA-2000, Tomey CASIA2, LenStar LS900

Sponsor:

Tomey Corporation

Code:

NCT06065072

Conditions

Cataract

Aphakic Eye

Pseudophakia

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Optical measurement

Study Details

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.

Conditions

Cataract

Aphakic Eye

Pseudophakia

Study ID

NCT06065072

Start date

Jun 23, 2023

Status verified date

Sep, 2023

Completion date

Oct 31, 2023

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

167 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal

Cataract

Special eye

Interventions

Optical measurement

Optical measurements by optical biometers and an OCT

Primary outcome measure

  • Agreement between the test devices and predicate device [ Time Frame: Through study completion, approximately 4 months ]
  • Precision of the test devices [ Time Frame: Through study completion, approximately 4 months ]
  • Safety of the test devices [ Time Frame: Through study completion, approximately 4 months ]

Central Contacts and Locations

Central contacts

Locations

NorthEast Eye Research Associates

Recruiting

Woburn, Massachusetts, United States, 01801

Contacts

More Information

Sponsor

Tomey Corporation

Last update posted

Oct 3, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tomey Corporation on 2023-10-03.