Triton Agreement and Precision Study

June 6, 2022 updated by: Topcon Medical Systems, Inc.

Topcon DRI OCT Triton Agreement and Precision Study

To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.

Study Overview

Detailed Description

The objectives of this study are to compare the agreement and precision between Topcon DRI OCT Triton and 3D OCT-1 Maestro with RDB by measuring the thickness layers.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Willmar, Minnesota, United States, 56201
        • Fischer Laser Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects presenting with Glaucoma, Retinal Diseases, or with no Ocular Pathology.

Description

Inclusion Criteria for Normal Group

  1. Subjects 18 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable)
  4. IOP ≤ 21 mmHg bilaterally
  5. BCVA 20/40 or better bilaterally

Exclusion Criteria for Normal Group

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images
  3. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%
  4. Visual field defects consistent with glaucomatous optic nerve damage based on 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."
  5. Narrow angle
  6. History of leukemia, dementia or multiple sclerosis
  7. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Glaucoma Group

  1. Subjects 18 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. BCVA 20/40 or better in the study eye
  4. Visual field defects consistent with glaucomatous optic nerve damage based on 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."
  5. 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 optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
    2. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
    3. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

Exclusion Criteria for Glaucoma Group

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  3. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33% in the study eye
  4. Presence of any ocular pathology except glaucoma in the study eye (cataracts are acceptable)
  5. History of leukemia, dementia or multiple sclerosis
  6. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Retina Disease Group

  1. Subjects 18 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. Subjects presenting at the site with retinal disease
  4. IOP ≤ 21 mmHg in the study eye
  5. BCVA 20/400 or better in the study eye
  6. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others

Exclusion Criteria for Retinal Disease Group

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  3. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye (cataracts are acceptable)
  4. Narrow angle in the study eye
  5. History of leukemia, dementia or multiple sclerosis
  6. Concomitant use of hydroxychloroquine and chloroquine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects Presenting With Normal Eyes
Subjects with no known ocular diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes
Subjects presenting with Retinal Disease
Subjects with Retinal diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes
Subjects presenting with Glaucoma
Subjects with Glaucoma will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Thickness
Time Frame: 1 Minute
The thickness of the macula layer
1 Minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Charles Riesman, MS, Topcon Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2017

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Triton AP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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