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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272102
• Other study ID #: HD-OCT-GCA-2010-1
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: June 24, 2013
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2013
• Source: Carl Zeiss Meditec, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	Stanford Eye Institute	Palo Alto	California
United States	Utah Eye Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Carl Zeiss Meditec, Inc.	DataMed Devices Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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

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. — View Citation

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. — View 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. — View 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. — View 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. Erratum in: Arch Ophthalmol. 2010 Sep;128(9):1150. De Moraes, Gustavo V [corrected to De Moraes, Carlos Gustavo]. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No