CompletedNCT04486976Updated Aug 30, 2021

Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software

An interventional study of Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti in Glaucoma and Cataract, sponsored by Tomey Corporation. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-30.

Sponsored by Tomey Corporation · Not applicable, Interventional, and Diagnostic

From the registry’s dates

Primary completion was Mar 2021, 5 years 8 months ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 134
Allocation: Randomized
Ages: 22 Years and older
Sex: All

Study summary

This study is a prospective comparative, randomized, single center study to gather agreement and precision data in all subjects.

Conditions studied

Glaucoma
Cataract

Browse trials for

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's enrollment of 134 is above the median of 61 across 964 interventional studies indexed under Glaucoma.

Browse Glaucoma 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.

Who can participate

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

Eligibility criteria

Inclusion Criteria - Normal Group:

Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the 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;

Exclusion Criteria - Normal Group:

Subjects unable to tolerate ophthalmic imaging;
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.

Inclusion Criteria - Cataract Group:

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;

Exclusion Criteria - Cataract Group:

Subjects unable to tolerate ophthalmic imaging;
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

Inclusion Criteria - Glaucoma Group:

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 with glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
1. Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
History of Visual field defects within the previous six (6) months from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
1. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
2. Glaucoma hemi-field test "outside normal limits."

Exclusion Criteria - Glaucoma Group:

Subjects unable to tolerate ophthalmic imaging;
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;
No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on white) result within 6 months of the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study 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.

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.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 134 participants (actual)

Study arms

Experimental
Normal
Device: Cornea/Anterior Segment OCT CASIA2 · Device: Optovue RTVue XR Avanti
Experimental
Glaucoma
Device: Cornea/Anterior Segment OCT CASIA2 · Device: Optovue RTVue XR Avanti
Experimental
Cataract
Device: Cornea/Anterior Segment OCT CASIA2 · Device: Optovue RTVue XR Avanti

Interventions

DeviceCornea/Anterior Segment OCT CASIA2
Cornea/Anterior Segment OCT CASIA2 The Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal thickness. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.
DeviceOptovue RTVue XR Avanti
Optovue RTVue XR Avanti The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.

What researchers measure

Primary outcomes

Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Thickness of Cornea
Time frame: Up to 30 days
Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Angle-Opening Distance Angle-Opening Distance
Time frame: Up to 30 days
Agreement of Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Trabecular-Iris Space Area
Time frame: Up to 30 days
Agreement of OCT image quality for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT and evaluation of visibility of predefined anatomical structures
Time frame: Up to 30 days
Precision of the Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Corneal thickness
Time frame: Up to 30 days
Precision of the Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Angle-Opening Distance
Time frame: Up to 30 days
Precision of the Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Trabecular-Iris Space Area
Time frame: Up to 30 days
Precision of the Anterior Corneal Depth measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Anterior Corneal Depth
Time frame: Up to 30 days
Precision of the Anterior Corneal Width measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Anterior Corneal Width
Time frame: Up to 30 days
Precision of the Pupil Diameter measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Pupil Diameter
Time frame: Up to 30 days
Precision of the Ks (steep meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Ks (steep meridian)
Time frame: Up to 30 days
Precision of the Kf (flat meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Kf (flat meridian)
Time frame: Up to 30 days
Precision of the Corneal Cylinder measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Corneal Cylinder
Time frame: Up to 30 days
Precision of the Average Keratometry measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Average Keratometry
Time frame: Up to 30 days
Precision of the Angle Recess Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Angle Recess Area
Time frame: Up to 30 days
Precision of the Trabecular-Iris Angle measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Trabecular-Iris Angle
Time frame: Up to 30 days

Secondary outcomes

Adverse Events
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational device but not necessarily related to the investigational device.
Time frame: Up to 30 days

Study locations

1 site

Andover Eye Associates
Andover, Massachusetts 01810, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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

Ran from Jun 2020 to primary completion in Mar 2021, 8 months.

Of 58 industry-sponsored interventional studies with no phase under Glaucoma, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's 8 months is below that.

Counting every sponsor, half of 287 studies reached it within 30 months; a quarter within 12 and three quarters within 53.

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

Registered: Jul 22, 2020
First posted: Jul 27, 2020
StartActual: Jun 27, 2020
Primary completionActual: Mar 5, 2021
CompletionActual: Mar 5, 2021
Last update: Aug 30, 2021

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 Aug 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04486976
Lead sponsor: Tomey Corporation
Responsible party: Sponsor
First posted: Jul 27, 2020
Start date: Jun 27, 2020
Primary completion: Mar 5, 2021
Completion: Mar 5, 2021
Last update: Aug 30, 2021

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Glaucoma →

Other studies from this sponsor

Tomey Corporation

Start the discussion