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
  Purpose

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


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma

Resource links provided by NLM:


Further study details as provided by Carl Zeiss Meditec, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 119
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glaucoma
subjects with glaucoma

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272102

Locations
United States, California
Stanford Eye Institute
Palo Alto, California, United States, 94303
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
United States, Texas
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
United States, Utah
Utah Eye Institute
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
DataMed Devices Inc.
Investigators
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
  More Information

Publications:
Mori S, Hangai M, Sakamoto A, Yoshimura N. Spectral-domain Optical Coherence Tomography Measurement of Macular Volume for Diagnosing Glaucoma. J Glaucoma 2010 (E-pub ahead of print).
Hodapp E, Parrish RK II, Anderson DR. Clinical Decisions in Glaucoma. St. Louis, MO: Mosby; 1993:52- 61

Responsible Party: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT01272102     History of Changes
Other Study ID Numbers: HD-OCT-GCA-2010-1
Study First Received: January 5, 2011
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ganglion Cysts
Glaucoma
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 27, 2014