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

Launched by TOMEY CORPORATION · Sep 26, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing three different devices used for eye scans in patients with cataracts and those who have had lens replacement surgery. Researchers want to see how accurately and consistently these devices measure important eye features. If you're 22 years or older, can follow instructions, and either have cataracts or have had surgery on your eye, you might be eligible to participate.

Participants will undergo several eye scans with each device, and the study will analyze how precise the measurements are and how much they agree with each other. If you join, you can expect to attend some scheduled appointments at a clinic where the scans will be done. It's important to note that certain conditions, like having an active eye infection or recent eye surgery, may prevent you from participating. Your safety and the accuracy of the results are the top priorities in this study.

Gender

ALL

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.