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Triton Agreement and Precision Study

Sponsor
Topcon Medical Systems, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03080714
Collaborator
(none)
88
Enrollment
1
Location
7.6
Actual Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Topcon DRI OCT Triton (plus)
  • Device: 3D OCT-1 Maestro

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 Design

Study Type:
Observational
Actual Enrollment :
88 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Topcon DRI OCT Triton Agreement and Precision Study
Actual Study Start Date :
Mar 13, 2017
Actual Primary Completion Date :
Aug 30, 2017
Actual Study Completion Date :
Oct 30, 2017

Arms and Interventions

Arm 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

Device: Topcon DRI OCT Triton (plus)
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes

Device: 3D OCT-1 Maestro
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

Device: Topcon DRI OCT Triton (plus)
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes

Device: 3D OCT-1 Maestro
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

Device: Topcon DRI OCT Triton (plus)
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes

Device: 3D OCT-1 Maestro
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes

Outcome Measures

Primary Outcome Measures

  1. Retinal Thickness [1 Minute]

    The thickness of the macula layer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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:

  5. 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;

  6. Glaucoma hemi-field test "outside normal limits."

  7. Narrow angle

  8. History of leukemia, dementia or multiple sclerosis

  9. 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:

  5. 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;

  6. Glaucoma hemi-field test "outside normal limits."

  7. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

  8. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;

  9. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or

  10. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fischer Laser Eye Center Willmar Minnesota United States 56201

Sponsors and Collaborators

  • Topcon Medical Systems, Inc.

Investigators

  • Study Chair: Charles Riesman, MS, Topcon Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT03080714
Other Study ID Numbers:
  • Triton AP
First Posted:
Mar 15, 2017
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Topcon Medical Systems, Inc.
no known ocular pathology
Glaucoma
Retinal Disease
Additional relevant MeSH terms:
Eye Diseases

Study Results

No Results Posted as of Jun 8, 2022