Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01417858
Status:
UNKNOWN
Last Update Posted:
2011-08-16
First Post:
2011-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-15', 'studyFirstSubmitDate': '2011-08-15', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intra-ocular pressure increase', 'timeFrame': 'one year', 'description': 'mean intra-ocular pressure increase after laser peripheral iridotomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intra-ocular pressure', 'iridectomy', 'gonioscopy', 'ocular tonometry'], 'conditions': ['Glaucoma, Narrow Angle']}, 'referencesModule': {'references': [{'pmid': '3795210', 'type': 'BACKGROUND', 'citation': 'Brazier DJ. Neodymium-YAG laser iridotomy. J R Soc Med. 1986 Nov;79(11):658-60. doi: 10.1177/014107688607901115.'}, {'pmid': '11382625', 'type': 'BACKGROUND', 'citation': 'Chen TC, Ang RT, Grosskreutz CL, Pasquale LR, Fan JT. Brimonidine 0.2% versus apraclonidine 0.5% for prevention of intraocular pressure elevations after anterior segment laser surgery. Ophthalmology. 2001 Jun;108(6):1033-8. doi: 10.1016/s0161-6420(01)00545-0.'}, {'pmid': '16246772', 'type': 'BACKGROUND', 'citation': 'Chen TC. Brimonidine 0.15% versus apraclonidine 0.5% for prevention of intraocular pressure elevation after anterior segment laser surgery. J Cataract Refract Surg. 2005 Sep;31(9):1707-12. doi: 10.1016/j.jcrs.2005.02.035.'}, {'pmid': '3328316', 'type': 'BACKGROUND', 'citation': 'Drake MV. Neodymium:YAG laser iridotomy. Surv Ophthalmol. 1987 Nov-Dec;32(3):171-7. doi: 10.1016/0039-6257(87)90092-0.'}, {'pmid': '10464738', 'type': 'BACKGROUND', 'citation': 'Hartenbaum D, Wilson H, Maloney S, Vacarelli L, Orillac R, Sharpe E. A randomized study of dorzolamide in the prevention of elevated intraocular pressure after anterior segment laser surgery. Dorzolamide Laser Study Group. J Glaucoma. 1999 Aug;8(4):273-5.'}, {'pmid': '15258021', 'type': 'BACKGROUND', 'citation': 'Kashiwagi K, Abe K, Tsukahara S. Quantitative evaluation of changes in anterior segment biometry by peripheral laser iridotomy using newly developed scanning peripheral anterior chamber depth analyser. Br J Ophthalmol. 2004 Aug;88(8):1036-41. doi: 10.1136/bjo.2003.036715.'}, {'pmid': '6548087', 'type': 'BACKGROUND', 'citation': 'Khodadoust AA, Arkfeld DF, Caprioli J, Sears ML. Ocular effect of neodymium-YAG laser. Am J Ophthalmol. 1984 Aug 15;98(2):144-52. doi: 10.1016/0002-9394(87)90348-5.'}, {'pmid': '3513746', 'type': 'BACKGROUND', 'citation': 'Robin AL, Arkell S, Gilbert SM, Goossens AA, Werner RP, Korshin OM. Q-switched neodymium-YAG laser iridotomy. A field trial with a portable laser system. Arch Ophthalmol. 1986 Apr;104(4):526-30. doi: 10.1001/archopht.1986.01050160082017.'}, {'pmid': '6548856', 'type': 'BACKGROUND', 'citation': 'Schrems W, Eichelbronner O, Krieglstein GK. The immediate IOP response of Nd-YAG-laser iridotomy and its prophylactic treatability. Acta Ophthalmol (Copenh). 1984 Oct;62(5):673-80. doi: 10.1111/j.1755-3768.1984.tb05794.x.'}, {'pmid': '8058261', 'type': 'BACKGROUND', 'citation': 'Wetzel W. Ocular aqueous humor dynamics after photodisruptive laser surgery procedures. Ophthalmic Surg. 1994 May;25(5):298-302.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the intra-ocular (IOP) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).', 'detailedDescription': 'Postoperative IOP elevation is one of the most common complications after LPI.Previous studies showed that brimonidine 0.2% is effective in blunting IOP spikes after LPI.This prospective randomized double-masked interventional study will include patients with bilateral narrow angles, defined by irido-trabecular contact in \\>180o on gonioscopy.Pilocarpine 1% will be used in both eyes, and 30 minutes later, brimonidine 0.1% randomly used in one eye and brimonidine 0.2% in the contra-lateral eye. LPI with Nd:YAG laser is performed 30 minutes later in both eyes by a single glaucoma specialist. IOP measurements are assessed before the use of any eyedrop (basal IOP), 30 minutes after pilocarpine (pre-brimonidine), and 30, 60, 120, 180 minutes after LPI. Pachymetry, ultrasonic biometry, gonioscopy, and total YAG laser energy are recorded. Non-parametric test will be used for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral narrow angles, defined by irido-trabecular contact in \\>180o on gonioscopy\n\nExclusion Criteria:\n\n* previous cataract surgery'}, 'identificationModule': {'nctId': 'NCT01417858', 'briefTitle': 'Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Paraná'}, 'officialTitle': 'Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%', 'orgStudyIdInfo': {'id': '0299.0.208.000-10'}, 'secondaryIdInfos': [{'id': '2376.270/2010-11', 'type': 'OTHER', 'domain': 'Hospital de Clinicas - UFPR - Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'brimonidine 0.2%', 'interventionNames': ['Procedure: YAG laser peripheral iridotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'brimonidine 0.1%', 'interventionNames': ['Procedure: YAG laser peripheral iridotomy']}], 'interventions': [{'name': 'YAG laser peripheral iridotomy', 'type': 'PROCEDURE', 'otherNames': ['Alphagan'], 'description': '1 drop 30 minutes before yag laser iridotomy', 'armGroupLabels': ['brimonidine 0.2%']}, {'name': 'YAG laser peripheral iridotomy', 'type': 'PROCEDURE', 'otherNames': ['Alphagan z'], 'description': '1 drop 30 minutes before yag laser iridotomy', 'armGroupLabels': ['brimonidine 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80060-150', 'city': 'Curitiba', 'state': 'Paraná', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Lucas Shiokawa', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lisandro Sakata', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dayane Issaho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universidade Federal do Parana', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}], 'centralContacts': [{'name': 'Lucas Shiokawa, MD', 'role': 'CONTACT', 'email': 'lucasshiokawa@yahoo.com.br', 'phone': '55 41 91432398'}, {'name': 'Dayane Issaho, MD', 'role': 'CONTACT', 'email': 'day_issaho@yahoo.com.br'}], 'overallOfficials': [{'name': 'Lucas Shiokawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Parana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Paraná', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lucas Shiokawa', 'oldOrganization': 'Universidade Federal do Parana'}}}}