Clinical trial NCT03080714: Triton Agreement and Precision Study
Official title: Topcon DRI OCT Triton Agreement and Precision Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Eyes
Eye Diseases
Keywords: no known ocular pathology
Glaucoma
Retinal Disease
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2017-03-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects presenting with Glaucoma, Retinal Diseases, or with no Ocular Pathology.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retinal Thickness
timeFrame: 1 Minute
Secondary outcomes:
Other outcomes:
Locations:
city: Willmar
country: United States
facility: Fischer Laser Eye Center
state: Minnesota
Study officials:
affiliation: Topcon Corporation
name: Charles Riesman, MS
role: STUDY_CHAIR
References: