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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02045823
Other study ID # Maestro2000AP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date March 2014

Study information

Verified date June 2022
Source Topcon Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States New York VA Jamaica New York

Sponsors (1)

Lead Sponsor Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal Thickness Day 1
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