Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT01272102
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2011-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2011-01-05', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '19744726', 'type': 'BACKGROUND', '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.'}, {'pmid': '19597108', 'type': 'BACKGROUND', '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.'}, {'pmid': '9479279', 'type': 'BACKGROUND', '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. doi: 10.1016/s0161-6420(98)92743-9.'}, {'pmid': '20164794', 'type': 'BACKGROUND', '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.'}, {'pmid': '19834029', 'type': 'BACKGROUND', '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.'}, {'pmid': '20435603', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Hodapp E, Parrish RK II, Anderson DR. Clinical Decisions in Glaucoma. St. Louis, MO: Mosby; 1993:52- 61'}, {'pmid': '3203132', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion Cell Analysis (GCA) average thickness.', 'detailedDescription': 'To determine the area under the Receiver Operator Characteristic Curve (AUC) for the following GCA parameters:\n\n1. Minimum thickness\n2. Supero-temporal thickness\n3. Superior thickness\n4. Supero-nasal thickness\n5. Infero-temporal thickness\n6. Inferior thickness\n7. Infero-nasal thickness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 40 years or older\n* Diagnosed to have glaucoma by the Principal Investigator or co-investigator\n* Able and willing to make the required study visits\n* Able and willing to give consent and follow study instructions\n\nExclusion Criteria:\n\nOphthalmic:\n\n* Best corrected visual acuity in either eye worse than 20/40 on a Snellen chart or on a Snellen equivalent acuity chart.\n* Refractive error outside -12.00D to +8.00D spherical range or \\>-3.00D cylinder.\n* Previous vitreoretinal surgery in study eye.\n* Vitreoretinal traction or epiretinal membrane in the study eye.\n* Any active infection of anterior or posterior segments.\n* Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal disease in the study eye upon dilated examination, or upon evaluation of retinal photos.\n\nSystemic:\n\n* History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis.\n* A life threatening or debilitating disease.\n* 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).\n* 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.).\n* Concomitant use of hydrochloroquine and/or chloroquine.'}, 'identificationModule': {'nctId': 'NCT01272102', 'briefTitle': 'Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec, Inc.'}, 'officialTitle': 'Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma', 'orgStudyIdInfo': {'id': 'HD-OCT-GCA-2010-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma', 'description': 'subjects with glaucoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Eye Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glaucoma Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Eye Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Donald Budenz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bascom Palmer Eye Institute'}, {'name': 'Robert Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Eye Institute'}, {'name': 'Arvind Neelakantan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glaucoma Associates of Texas'}, {'name': 'Alan Crandall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utah Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'DataMed Devices Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}