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OpenTrials
Completed

NCT Number: NCT01986478

OCT Reference Database

To collect data for a reference database.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Horizon Eye Specialist & Laser Center, Scottsdale, Arizona, United States

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About this study

Collection of multiple subjects to create a reference database.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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 normal eyes (eyes without pathology)
  • IOP ≤ 21 mmHg bilaterally
  • BCVA 20/40 or better (each eye)
  • Both eyes must be free of eye disease

Exclusion criteria

  • 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

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: Reference Database Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2013
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.

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