Skip to main content
OpenTrials
Completed

NCT Number: NCT02045823

OCT 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York VA

Jamaica, New York, 11425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Normal Group

  • 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

Exclusion criteria

for Normal Group

  • 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

Inclusion criteria

for Glaucoma Group

  • 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

Exclusion criteria

for Glaucoma Group

  • 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 unreliable, defined as fixation losses> 33% or false positives> 25%, or false negatives > 25% in the study eye
  • Presence of any ocular pathology except glaucoma in the study eye
  • 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
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Inclusion criteria

for Retina Disease Group

  • 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 retinal disease
  • lOP<= 21mmHg in the study eye
  • BCVA 20/400 or better in the study eye
  • 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

  • Subjects unable to tolerate ophthalmic imaging
  • Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  • Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye
  • 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
  • Narrow angle in the study eye
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Treatment and study plan

Primary outcomes

  1. Retinal Thickness

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Topcon Medical Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2014
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.