CataractNCT06065072
Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900
An observational study of Cataract and Aphakic Eye, run by Tomey Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Aphakic Eye, Pseudophakia
- What is being tested?
- Optical measurement
- Type of treatment
- Medical device
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NorthEast Eye Research Associates
Woburn, Massachusetts, 01801
Deep Soni, 857-250-9178, deep@neeraeye.com
About this study
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.
Read more
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.
- Conditions
- Cataract, Aphakic Eye, Pseudophakia
- Being tested
- Optical measurement
- Medical subject headings
- Cataract, Aphakia, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical measurementDevice
Optical measurements by optical biometers and an OCT
| Study group | Role | What they receive |
|---|---|---|
| Normal | Not described Receives: Device: Optical measurement | |
| Cataract | Not described Receives: Device: Optical measurement | |
| Special eye | Not described Receives: Device: Optical measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, approximately 4 months
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.
Measured: Through study completion, approximately 4 months
Safety of the test devices
Adverse events reported will be listed by subject.
Measured: Through study completion, approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start23 Jun 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomey Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ioanis Panagiotopoulos, Dr., Principal investigator, NorthEast Eye Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065072
- Sponsor's protocol ID
- Tomey OA-2000-001
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900
- ClinicalTrials.gov ID
- NCT06065072
- Acronym / sponsor ID
- Tomey OA-2000-001
- Conditions
- Cataract, Aphakic Eye, Pseudophakia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Tomey CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: Optical measurement |
| Cataract | – | Device: Optical measurement |
| Special eye | – | Device: Optical measurement |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (12 listed)
- 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.
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical measurementOptical measurements by optical biometers and an OCT | Device | Cataract, Normal, Special eye |
Primary outcome
Agreement between the test devices and predicate device
Time frame: Through study completion, approximately 4 months
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.
Precision of the test devices
Time frame: Through study completion, approximately 4 months
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.
Safety of the test devices
Time frame: Through study completion, approximately 4 months
Adverse events reported will be listed by subject.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioanis Panagiotopoulos, Dr. principal investigator
NorthEast Eye Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Aphakic Eye, run by Tomey Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deep Soni (857-250-9178, deep@neeraeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the test devices and predicate device (time frame: Through study completion, approximately 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.