Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 4:00 PM
Study NCT ID:
NCT01488032
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2011-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057066', 'term': 'Low Tension Glaucoma'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-08', 'studyFirstSubmitDate': '2011-12-01', 'studyFirstSubmitQcDate': '2011-12-07', 'lastUpdatePostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RNFL in different segments', 'timeFrame': 'up to 9 Months', 'description': 'RNFL in upper, lower, temporal and nasal segments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Normal Tension Glaucoma', 'High Tension Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to prove if there is any difference in the nerve fiber layer between patients with normal- and high-tension-glaucoma with similar structural optic nerve head parameters.', 'detailedDescription': 'It is till now not definitely clear whether normal- and high-tension glaucoma are different forms of the same disease and whether they have similar pathogenetic mechanisms. Spectral domain optical coherence tomography (SD-OCT) is supposed to objectively evaluate retinal nerve fiber layer (RNFL) thickness. The investigators propose a study to compare the RNFL in patients with normal- and high-tension-glaucoma. In order to exclude other possible differences,which could influence the results, only patients with similar structural optic nerve head damage in both groups will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic University hospital of Dresden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* persons over 18 years\n* men or women\n* with normal- and high-tension glaucoma\n\nExclusion Criteria:\n\n* cataract\n* cloudy cornea and other conditions with bad visualisation quality of optic nerve head\n* optic nerve atrophy except glaucomatous'}, 'identificationModule': {'nctId': 'NCT01488032', 'briefTitle': 'Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma With Similar Structural Optic Nerve Damage', 'orgStudyIdInfo': {'id': 'EK 322102010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high-tension glaucoma', 'description': 'subjects with IOP\\>22 mmHg without eyedrops and signs of glaucomatous optic nerve damage'}, {'label': 'low-tension glaucoma', 'description': 'subjects with IOP\\<22 mmHg without eyedrops and signs of glaucomatous optic nerve damage'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}