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

Completed

• Conditions: Glaucoma

• Registration Number: NCT01272102
• Lead Sponsor: Carl Zeiss Meditec, Inc.

Brief Summary

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

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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters.	Study was released before December 1, 2012

Trial Locations

Locations (4)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

Glaucoma Associates of Texas; 🇺🇸 Dallas, Texas, United States

Stanford Eye Institute; 🇺🇸 Palo Alto, California, United States

Utah Eye Institute; 🇺🇸 Salt Lake City, Utah, United States