Comparing three optical measurement devices for cataract assessment

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

This study is testing three different eye measurement devices to see which one works best for assessing cataracts and other eye conditions in patients.

Quick facts

• Study type: Observational
• Enrollment: 167 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Tomey Corporation (industry)
• Locations: 1 site (Woburn, Massachusetts)
• Trial ID: NCT06065072 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the performance of three optical measurement devices: the Tomey OA-2000, Tomey CASIA2, and LenStar LS900, in patients with cataracts and other eye conditions. Participants will undergo OCT scans using each device, and the study will analyze the precision and agreement of the measurements obtained. The study will include a normal cohort as well as cohorts with cataracts and special eyes, ensuring a comprehensive evaluation of the devices' effectiveness. The analyses will focus on obtaining reliable and consistent data from the scans to determine the best device for clinical use.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 22 and older with cataracts or those with special eye conditions.

Not a fit: Patients with conditions unrelated to cataracts or those unable to comply with study protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of cataract assessments, leading to better treatment outcomes for patients.

How similar studies have performed: Previous studies have shown success in comparing optical measurement devices, indicating that this approach is promising.

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.

Where this trial is running

Woburn, Massachusetts

• NorthEast Eye Research Associates — Woburn, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Ioanis Panagiotopoulos, Dr. — NorthEast Eye Research Associates
• Study coordinator: Deep Soni

Conditions: Cataract, Aphakic Eye, Pseudophakia