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Completed

NCT Number: NCT01272102

Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma

To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion Cell Analysis (GCA) average thickness.

Completed

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Eye Institute, Palo Alto, California, United States

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About this study

To determine the area under the Receiver Operator Characteristic Curve (AUC) for the following GCA parameters:

  • Minimum thickness
  • Supero-temporal thickness
  • Superior thickness
  • Supero-nasal thickness
  • Infero-temporal thickness
  • Inferior thickness
  • Infero-nasal thickness

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age of 40 years or older
  • Diagnosed to have glaucoma by the Principal Investigator or co-investigator
  • Able and willing to make the required study visits
  • Able and willing to give consent and follow study instructions

Exclusion criteria

Ophthalmic:

  • Best corrected visual acuity in either eye worse than 20/40 on a Snellen chart or on a Snellen equivalent acuity chart.
  • Refractive error outside -12.00D to +8.00D spherical range or >-3.00D cylinder.
  • Previous vitreoretinal surgery in study eye.
  • Vitreoretinal traction or epiretinal membrane in the study eye.
  • Any active infection of anterior or posterior segments.
  • Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal disease in the study eye upon dilated examination, or upon evaluation of retinal photos.

Systemic:

  • History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis.
  • A life threatening or debilitating disease.
  • Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE).
  • Current or recent (within the past 14 days) use of an agent with photosensitizing properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.).
  • Concomitant use of hydrochloroquine and/or chloroquine.

Treatment and study plan

Primary outcomes

  1. To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters.

    Time frame: Study was released before December 1, 2012

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec, Inc.

Industry

Collaborators

  • DataMed Devices Inc.

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Jun 25, 2013

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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