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

This study has been completed.
Sponsor:
Collaborator:
DataMed Devices Inc.
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier:
NCT01272102
First received: January 5, 2011
Last updated: June 24, 2013
Last verified: June 2013

January 5, 2011
June 24, 2013
November 2010
March 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01272102 on ClinicalTrials.gov Archive Site
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Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma
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.

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

  1. Minimum thickness
  2. Supero-temporal thickness
  3. Superior thickness
  4. Supero-nasal thickness
  5. Infero-temporal thickness
  6. Inferior thickness
  7. Infero-nasal thickness
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Primary Care Clinic

Glaucoma
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Glaucoma
subjects with glaucoma

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01272102
HD-OCT-GCA-2010-1
Yes
Carl Zeiss Meditec, Inc.
Carl Zeiss Meditec, Inc.
DataMed Devices Inc.
Principal Investigator: Donald Budenz, MD Bascom Palmer Eye Institute
Principal Investigator: Robert Chang, MD Stanford Eye Institute
Principal Investigator: Arvind Neelakantan, MD Glaucoma Associates of Texas
Principal Investigator: Alan Crandall, MD Utah Eye Institute
Carl Zeiss Meditec, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP