OCT Agreement and Precision Study

Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Agreement and Precision Study

To demonstrate clinical substantial equivalence of 3D OCT-1 Maestro as comparable to the commercially available iVue and NW-300. Also, to demonstrate clinical substantial equivalence of 3D OCT-2000 Maestro as comparable to the commercially available NW-300.

Study Overview

• Status: Completed
• Conditions: Normal Eyes; Eyes With Glaucoma; Eyes With Retinal Disease

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• United States
  • New York
    • Jamaica, New York, United States, 11425
      • New York VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects that are Normal, or shows signs of Glaucoma, or Retinal 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 Criteria participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (eyes without pathology)
4. lOPs 21mmHg bilaterally
5. BCVA 20/40 or better (each eye)
6. Both eyes must be free of eye disease

Exclusion Criteria for Normal 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 abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%
4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses> 33% or false positives> 25%, or false negatives> 25%
5. Presence of any ocular pathology except for cataract
6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
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. Subjects presenting at the site with glaucoma
4. BCVA 20/40 or better in the study eye
5. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5% in the study eye

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> 33% or false positives> 25%, or false negatives > 25% in the study eye
4. Presence of any ocular pathology except glaucoma in the study eye
5. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning in the study eye
6. History of leukemia, dementia or multiple sclerosis
7. 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. lOP<= 21mmHg 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
4. Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning in the study eye
5. Narrow angle in the study eye
6. History of leukemia, dementia or multiple sclerosis
7. Concomitant use of hydroxychloroquine and chloroquine

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Normal; Normal results from clinical exam and free of ocular pathology
Glaucoma; Clinical exam with results consistent with glaucoma and visual field defects consistent with glaucoma
Retina; clinical exam with results consistent with retina pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retinal Thickness	Day 1

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.
• Investigators: Principal Investigator: Mike Sinai, PhD, Topcon Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 27, 2014

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: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: Maestro2000AP