OCT Agreement and Precision Study

NCT02045823 | Completed

• 1 other identifier: Maestro2000AP
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Eyes; Eyes With Glaucoma; Eyes With Retinal Disease

Outcome Measures

Primary Outcomes (1)

• Retinal Thickness

  Day 1

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects that are Normal, or shows signs of Glaucoma, or Retinal Ocular Pathology.

You may qualify if:

• Subjects 18 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to Criteria participate as evidenced by signing the informed consent
• Subjects presenting at the site with normal eyes (eyes without pathology)
• lOPs 21mmHg bilaterally
• BCVA 20/40 or better (each eye)
• Both eyes must be free of eye disease

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging
• Subject with ocular media not sufficiently clear to obtain acceptable OCT images
• HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5%
• 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%
• Presence of any ocular pathology except for cataract
• Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
• Narrow angle
• History of leukemia, dementia or multiple sclerosis
• Concomitant use of hydroxychloroquine and chloroquine
• Subjects 18 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects presenting at the site with glaucoma
• BCVA 20/40 or better in the study eye
• 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
• Subjects unable to tolerate ophthalmic imaging

Sponsors & Collaborators

• Topcon Medical Systems, Inc.: lead

Study Sites (1)

New York VA

Jamaica, New York, 11425, United States

Location

Study Officials

• Mike Sinai, PhD

  Topcon Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

US (1)