Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma
NCT ID: NCT01272102
Last Updated: 2013-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
119 participants
OBSERVATIONAL
2010-11-30
2011-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Glaucoma
subjects with glaucoma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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DataMed Devices Inc.
INDUSTRY
Carl Zeiss Meditec, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Budenz, MD
Role: PRINCIPAL_INVESTIGATOR
Bascom Palmer Eye Institute
Robert Chang, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Eye Institute
Arvind Neelakantan, MD
Role: PRINCIPAL_INVESTIGATOR
Glaucoma Associates of Texas
Alan Crandall, MD
Role: PRINCIPAL_INVESTIGATOR
Utah Eye Institute
Locations
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Stanford Eye Institute
Palo Alto, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
Utah Eye Institute
Salt Lake City, Utah, United States
Countries
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References
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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.
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.
Zeimer R, Asrani S, Zou S, Quigley H, Jampel H. Quantitative detection of glaucomatous damage at the posterior pole by retinal thickness mapping. A pilot study. Ophthalmology. 1998 Feb;105(2):224-31. doi: 10.1016/s0161-6420(98)92743-9.
Mori S, Hangai M, Sakamoto A, Yoshimura N. Spectral-domain optical coherence tomography measurement of macular volume for diagnosing glaucoma. J Glaucoma. 2010 Oct-Nov;19(8):528-34. doi: 10.1097/IJG.0b013e3181ca7acf.
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.
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.
Hodapp E, Parrish RK II, Anderson DR. Clinical Decisions in Glaucoma. St. Louis, MO: Mosby; 1993:52- 61
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.
Other Identifiers
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HD-OCT-GCA-2010-1
Identifier Type: -
Identifier Source: org_study_id
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