Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-01-22 @ 7:30 AM
Study NCT ID:
NCT01254006
Status:
COMPLETED
Last Update Posted:
2010-12-06
First Post:
2010-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005576', 'term': 'Colforsin'}, {'id': 'D012431', 'term': 'Rutin'}], 'ancestors': [{'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'lastUpdateSubmitDate': '2010-12-03', 'studyFirstSubmitDate': '2010-11-29', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retinal nerve fibres layer thickness'}], 'secondaryOutcomes': [{'measure': 'global risk threshold for glaucoma progression'}]}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'In this study the investigators are going to study the retinal nerve fibers layers (RNFL) modification of two groups of patients, one taking no drugs, the other taking forskolin, rutin and vitamins B1 and B2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (30-80 years);\n* Baseline Intraocular pressure (IOP) (20-32 mmHg): average untreated Intra Ocular Pressure (IOP) for both eyes as determined from 2 to 4 visits within a 6-months period;\n* Central Corneal Thickness (CCT) (475-650 µm): average of 3 different measurements from both eyes during the same visit;\n* Pattern standard deviation (PSD) (0,50-3,00 dB) average of both eyes as stated on the most recent visual field index report\n* Vertical Cup/Disk ratio (0,00-0,80): average of both eyes\n* All these data were entered into a calculator specially designed for STAR (Scoring Tool for assessing risk) II parameter. The patients were divided into low-, moderate- and high risk groups according to the result given by the calculator.\n\nExclusion Criteria:\n\n-other ocular pathologies than glaucoma'}, 'identificationModule': {'nctId': 'NCT01254006', 'briefTitle': 'Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'orgStudyIdInfo': {'id': 'GLA0110'}}, 'armsInterventionsModule': {'interventions': [{'name': 'forskolin, rutin and vitamins B1 and B2', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Latina', 'country': 'Italy', 'facility': 'Univerisity La Sapienza', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'collaborators': [{'name': 'vingolo enzo maria', 'class': 'UNKNOWN'}, {'name': 'domanico daniela', 'class': 'UNKNOWN'}, {'name': 'salvatore serena', 'class': 'UNKNOWN'}]}}}