Clinical Validation of New OCT System

NCT ID: NCT01809704

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-25
• Study Completion Date: 2013-07-03

Brief Summary

To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus

Conditions

Subjects Presenting With Normal or With Ocular Pathology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal

Normal results from clinical exam and free of ocular pathology.

No interventions assigned to this group

Glaucoma

Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.

No interventions assigned to this group

Retina

Clinical exam results consistent with retina pathology

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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 (eyes without pathology)

4. IOP ≤ 21 mmHg bilaterally

5. BCVA 20/40 or better bilaterally

6. Both eyes must be free of eye disease

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 < 1% in the study eye

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

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 < 1%

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

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 procedures 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

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 procedures 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Topcon Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Sinai, PhD

Role: PRINCIPAL_INVESTIGATOR

Director of Clinical Marketing

Locations

Hamilton Glaucoma Center

La Jolla, California, United States

Murray Fingeret

Jamaica, New York, United States

Vitreous Retina Macula Consultants of New York

New York, New York, United States

Countries

United States

Other Identifiers

DC-03267

Identifier Type: -

Identifier Source: org_study_id