Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT02141594
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2014-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Pole Asymmetry Analysis (PPAA) for Early 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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under curve for all the diagnostic parameters of optical coherence tomography', 'timeFrame': 'up to 32 weeks', 'description': 'This was a cross sectional study with one time measurement of the diagnostic parameters of the optical coherence tomography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '20164794', 'type': 'RESULT', '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': '20520570', 'type': 'RESULT', 'citation': 'Nakatani Y, Higashide T, Ohkubo S, Takeda H, Sugiyama K. Evaluation of macular thickness and peripapillary retinal nerve fiber layer thickness for detection of early glaucoma using spectral domain optical coherence tomography. J Glaucoma. 2011 Apr-May;20(4):252-9. doi: 10.1097/IJG.0b013e3181e079ed.'}, {'pmid': '19834029', 'type': 'RESULT', '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': '22079964', 'type': 'RESULT', 'citation': 'Rao HL, Babu JG, Addepalli UK, Senthil S, Garudadri CS. Retinal nerve fiber layer and macular inner retina measurements by spectral domain optical coherence tomograph in Indian eyes with early glaucoma. Eye (Lond). 2012 Jan;26(1):133-9. doi: 10.1038/eye.2011.277. Epub 2011 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'Spectrailis optical coherence tomography has come with a new posterior pole asymmetry analysis for glaucoma diagnosis. The aim of the investigators study was to assess its applicability in diagnosing early glaucoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '49 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive 80 eyes of 80 normal subjects and 76 eyes of 76 patients with early glaucoma were included for the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18 years\n* Best corrected visual acuity 20/40 or better\n* Refractive error within ±5D sphere and ±3D cylinder\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Media opacities preventing imaging\n* Intraocular surgery within the last 6 months\n* Any retinal or neurological disease other than glaucoma that could confound the results of visual field examination and OCT.'}, 'identificationModule': {'nctId': 'NCT02141594', 'acronym': 'PPAA', 'briefTitle': 'Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Dr T V Patel Eye Institute'}, 'officialTitle': 'Diagnostic Ability of Posterior Pole Asymmetry Analysis Parameters (PPAA) of Spectralis Optical Coherence Tomography (OCT) in Detecting Early Glaucoma', 'orgStudyIdInfo': {'id': 'OCT PPAA in early glaucoma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early glaucoma', 'description': 'The study group consisted of consecutive unilateral glaucoma patients, categorized as early stage by Hodapp-Anderson-Parrish classification.'}, {'label': 'Normal subjects', 'description': 'Normal control subjects had a normal ocular examination, Intraocular pressure (IOP) \\<22 mmHg, no past history of high IOP, no family history of glaucoma, normal optic disc morphology and visual field in both eyes. One eye of control subject was randomly selected.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '390001', 'city': 'Vadodara', 'state': 'Gujarat', 'country': 'India', 'facility': 'Dr TV Patel Eye Institute', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}], 'overallOfficials': [{'name': 'Paaraj R Dave, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr TV Patel Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr T V Patel Eye Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Paaraj Dave', 'investigatorAffiliation': 'Dr T V Patel Eye Institute'}}}}