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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Carl Zeiss Meditec, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
DataMed Devices Inc.
Information provided by:
Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier:
NCT01272102
First received: January 5, 2011
Last updated: January 6, 2011
Last verified: January 2011
  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.:

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: March 2011
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272102

Locations
United States, California
Stanford Eye Institute Recruiting
Palo Alto, California, United States, 94303
Contact: Patricia Mattio     650-721-6884        
Principal Investigator: Robert Chang, MD            
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Fouad Sayyad     305-505-0086     FElsayyad@med.miami.edu    
Principal Investigator: Don Budenz, MD            
United States, Texas
Glaucoma Associates of Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Michelle Smith     214-360-0000     msmith@glaucomaassociates.com    
Principal Investigator: Arvind Neelakantan, MD            
United States, Utah
Utah Eye Institute Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Anne Bagley     801-261-2113     abagley@axiamed.com    
Principal Investigator: Alan Crandall, MD            
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: Judith A. Brimacombe, 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: January 6, 2011
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 May 21, 2013