Status:
UNKNOWN
Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900
Lead Sponsor:
Tomey Corporation
Conditions:
Cataract
Aphakic Eye
Eligibility:
All Genders
22+ years
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 cri...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Normal Cohort:
- 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;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study.
- Inclusion Criteria - Cataract Cohort:
- 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;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study;
- 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):
- 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;
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
- Subjects who agree to participate in the study;
- Subjects diagnosed with one or both eyes having aphakia, pseudophakia or silicone oil.
- Exclusion Criteria - Normal Cohort:
- Subjects unable to tolerate ophthalmic imaging;
- Subjects who did not take off their contact lenses earlier than 15 minutes prior to the study;
- 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;
- Subjects that present with an active ocular infection in either eye;
- Subjects who have a history of ocular surgery, including laser therapy/surgery;
- 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:
- Subjects unable to tolerate ophthalmic imaging;
- Subjects who did not take off their contact lenses earlier than 15 minutes prior to the study;
- Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;
- Subjects that present with an active ocular infection in either eye;
- Subjects who have a history of ocular surgery, including laser therapy/surgery;
- 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):
- Subjects unable to tolerate ophthalmic imaging;
- Subjects who did not take off their contact lenses earlier than 15 minutes prior to the study;
- Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;
- Subjects that present with an active ocular infection in either eye;
- 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;
- Subjects with evidence of silicone oil emulsification;
- Subjects with silicone oil in the anterior chamber;
- Subjects with adherence of oil droplets to an intraocular lens.
Exclusion
Key Trial Info
Start Date :
June 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2023
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT06065072
Start Date
June 23 2023
End Date
October 31 2023
Last Update
October 3 2023
Active Locations (1)
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1
NorthEast Eye Research Associates
Woburn, Massachusetts, United States, 01801