Clinical trial NCT01272102: Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma
Official title: Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
Collaborators: name: DataMed Devices Inc.
First posted: 2011-01-07
Enrollment: 119
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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

Eligibility 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.

Primary outcomes:
measure: To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters.
timeFrame: Study was released before December 1, 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Eye Institute
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Utah Eye Institute
state: Utah
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Donald Budenz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford Eye Institute
name: Robert Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glaucoma Associates of Texas
name: Arvind Neelakantan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Utah Eye Institute
name: Alan Crandall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan O, Chopra V, Lu AT, Schuman JS, Ishikawa H, Wollstein G, Varma R, Huang D. Detection of macular ganglion cell loss in glaucoma by Fourier-domain optical coherence tomography. Ophthalmology. 2009 Dec;116(12):2305-14.e1-2. doi: 10.1016/j.ophtha.2009.05.025. Epub 2009 Sep 10.
citation: Wang M, Hood DC, Cho JS, Ghadiali Q, De Moraes CG, Zhang X, Ritch R, Liebmann JM. Measurement of local retinal ganglion cell layer thickness in patients with glaucoma using frequency-domain optical coherence tomography. Arch Ophthalmol. 2009 Jul;127(7):875-81. doi: 10.1001/archophthalmol.2009.145.
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citation: Seong M, Sung KR, Choi EH, Kang SY, Cho JW, Um TW, Kim YJ, Park SB, Hong HE, Kook MS. Macular and peripapillary retinal nerve fiber layer measurements by spectral domain optical coherence tomography in normal-tension glaucoma. Invest Ophthalmol Vis Sci. 2010 Mar;51(3):1446-52. doi: 10.1167/iovs.09-4258. Epub 2009 Oct 15.
citation: Kim NR, Lee ES, Seong GJ, Kim JH, An HG, Kim CY. Structure-function relationship and diagnostic value of macular ganglion cell complex measurement using Fourier-domain OCT in glaucoma. Invest Ophthalmol Vis Sci. 2010 Sep;51(9):4646-51. doi: 10.1167/iovs.09-5053. Epub 2010 Apr 30.
citation: Hodapp E, Parrish RK II, Anderson DR. Clinical Decisions in Glaucoma. St. Louis, MO: Mosby; 1993:52- 61
citation: DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.