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
Recruitment status was Recruiting
Sponsor:
Carl Zeiss Meditec, Inc.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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:
- Minimum thickness
- Supero-temporal thickness
- Superior thickness
- Supero-nasal thickness
- Infero-temporal thickness
- Inferior thickness
- 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