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RecruitingNCT06065072Updated Oct 3, 2023

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

An observational study in Cataract, Aphakic Eye and Pseudophakia, sponsored by Tomey Corporation. Recruiting at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Tomey Corporation · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
167
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract
  • Aphakic Eye
  • Pseudophakia
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 167 is above the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Tomey Corporation is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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)

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
167 participants (estimated)
Patient registry
No

Groups and cohorts

  • Normal

    Device: Optical measurement

  • Cataract

    Device: Optical measurement

  • Special eye

    Device: Optical measurement

Interventions

  • DeviceOptical measurement

    Optical measurements by optical biometers and an OCT

06

What researchers measure

Primary outcomes

  1. Agreement between the test devices and predicate device

    Agreement between each of the test devices and the predicate device will be evaluated by the mean difference and SD, the 95% limits of agreement (LOA), the Bland-Altman plots, and Deming regression for each subject population.

    Time frame: Through study completion, approximately 4 months

  2. Precision of the test devices

    A crossed two-way random-effects analysis of variance (ANOVA) model will be used to estimate the repeatability and reproducibility limits of each scan parameter by subject population and study device (test and predicate device). This ANOVA model will include the configuration, subject, and interaction between configuration and subject as the factors. Repeatability and reproducibility standard deviations, as well as the corresponding coefficient of variations (CVs), will be calculated using this ANOVA model.

    Time frame: Through study completion, approximately 4 months

  3. Safety of the test devices

    Adverse events reported will be listed by subject.

    Time frame: Through study completion, approximately 4 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Oct 2023, 4 months after the start.

Of 67 industry-sponsored observational studies under Cataract, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 4 months is below that.

Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2023
First posted
Oct 3, 2023
StartActual
Jun 23, 2023
Primary completionEst.
Oct 31, 2023
CompletionEst.
Oct 31, 2023
Last update
Oct 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06065072
Lead sponsor
Tomey Corporation
Responsible party
Sponsor
First posted
Oct 3, 2023
Start date
Jun 23, 2023
Primary completion
Oct 31, 2023 (estimated)
Completion
Oct 31, 2023 (estimated)
Last update
Oct 3, 2023

Study contacts

Deep Soni
Contact
deep@neeraeye.com
857-250-9178
Ioanis Panagiotopoulos, Dr.
principal investigator · NorthEast Eye Research Associates

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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