Clinical trial NCT06065072: Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900
Official title: Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Aphakic Eye
Pseudophakia
Lead sponsor: Tomey Corporation
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 167
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal subjects (22 years of age or older) Cataract subjects (22 years of age or older), Special eyes subjects (22 years of age or older)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Agreement between the test devices and predicate device
timeFrame: Through study completion, approximately 4 months
measure: Precision of the test devices
timeFrame: Through study completion, approximately 4 months
measure: Safety of the test devices
timeFrame: Through study completion, approximately 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: NorthEast Eye Research Associates
state: Massachusetts
Study officials:
affiliation: NorthEast Eye Research Associates
name: Ioanis Panagiotopoulos, Dr.
role: PRINCIPAL_INVESTIGATOR
References: