OCT Agreement and Precision Study

• Sponsor: Topcon Medical Systems, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02045823
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 34

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Eyes; Eyes With Glaucoma; Eyes With Retinal Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 66 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Agreement and Precision Study
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Retinal Thickness [Day 1]

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York VA	Jamaica	New York	United States	11425

Sponsors and Collaborators

• Topcon Medical Systems, Inc.

Investigators

• Principal Investigator: Mike Sinai, PhD, Topcon Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topcon Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT02045823
• Other Study ID Numbers: Maestro2000AP
• First Posted: Jan 27, 2014
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Additional relevant MeSH terms: Retinal Diseases

Study Results

No Results Posted as of Jun 8, 2022