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

NCT01272102 | Completed DMC

• 1 other identifier: HD-OCT-GCA-2010-1
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Glaucoma

subjects with glaucoma

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead
• DataMed Devices Inc.: collaborator

Study Sites (4)

Stanford Eye Institute

Palo Alto, California, 94303, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location

Utah Eye Institute

Salt Lake City, Utah, 84107, United States

Location

Related Publications (8)

• 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.

  PMID: 19744726 BACKGROUND

• 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.

  PMID: 19597108 BACKGROUND

• 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.

  PMID: 9479279 BACKGROUND

• 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.

  PMID: 20164794 BACKGROUND

• 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.

  PMID: 19834029 BACKGROUND

• 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.

  PMID: 20435603 BACKGROUND

• Hodapp E, Parrish RK II, Anderson DR. Clinical Decisions in Glaucoma. St. Louis, MO: Mosby; 1993:52- 61

  BACKGROUND

• 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.

  PMID: 3203132 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 7, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (4)