Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT01691651
Status:
COMPLETED
Last Update Posted:
2014-10-21
First Post:
2012-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Botulinum Toxin A for the Treatment of Keratoconus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-18', 'studyFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Corrected visual acuity', 'timeFrame': 'Eighteen months.', 'description': 'We will evaluate the corrected visual acuity (unit of measure=logMAR)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.'}], 'primaryOutcomes': [{'measure': 'Measurement of the palpebral fissure', 'timeFrame': 'Eighteen months.', 'description': 'We will evaluate the change in palpebral fissure (unit of measure=millimetre)by 18 months.These time points will be included:baseline, 3, 6, 12 and 18 months.'}], 'secondaryOutcomes': [{'measure': 'Corneal topography', 'timeFrame': 'Eighteen months.', 'description': 'We will evaluate corneal topography \\[flattest keratometry, steepest keratometry and average keratometry(unit of measure=diopters)\\]by 18 months.These time points will be included:baseline, 3, 6,12 and 18 months.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Keratoconus', 'Tetanus toxin'], 'conditions': ['Keratoconus']}, 'referencesModule': {'references': [{'pmid': '9493273', 'type': 'BACKGROUND', 'citation': 'Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.'}, {'pmid': '11778802', 'type': 'BACKGROUND', 'citation': 'Edwards M, McGhee CN, Dean S. The genetics of keratoconus. Clin Exp Ophthalmol. 2001 Dec;29(6):345-51. doi: 10.1046/j.1442-9071.2001.d01-16.x.'}, {'pmid': '14640429', 'type': 'BACKGROUND', 'citation': 'Miranda D, Sartori M, Francesconi C, Allemann N, Ferrara P, Campos M. Ferrara intrastromal corneal ring segments for severe keratoconus. J Refract Surg. 2003 Nov-Dec;19(6):645-53. doi: 10.3928/1081-597X-20031101-06.'}, {'pmid': '19772256', 'type': 'BACKGROUND', 'citation': 'Kymionis GD, Kontadakis GA, Kounis GA, Portaliou DM, Karavitaki AE, Magarakis M, Yoo S, Pallikaris IG. Simultaneous topography-guided PRK followed by corneal collagen cross-linking for keratoconus. J Refract Surg. 2009 Sep;25(9):S807-11. doi: 10.3928/1081597X-20090813-09. Epub 2009 Sep 11.'}, {'pmid': '12719068', 'type': 'BACKGROUND', 'citation': 'Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.'}, {'pmid': '22265143', 'type': 'BACKGROUND', 'citation': 'Renesto Ada C, Melo LA Jr, Sartori Mde F, Campos M. Sequential topical riboflavin with or without ultraviolet a radiation with delayed intracorneal ring segment insertion for keratoconus. Am J Ophthalmol. 2012 May;153(5):982-993.e3. doi: 10.1016/j.ajo.2011.10.014. Epub 2012 Jan 20.'}, {'pmid': '10906086', 'type': 'BACKGROUND', 'citation': 'Bawazeer AM, Hodge WG, Lorimer B. Atopy and keratoconus: a multivariate analysis. Br J Ophthalmol. 2000 Aug;84(8):834-6. doi: 10.1136/bjo.84.8.834.'}, {'pmid': '11004300', 'type': 'BACKGROUND', 'citation': 'Kim T, Khosla-Gupta B, Debacker C. Blepharoptosis-induced superior keratoconus. Am J Ophthalmol. 2000 Aug;130(2):232-4. doi: 10.1016/s0002-9394(00)00497-9.'}, {'pmid': '6830745', 'type': 'BACKGROUND', 'citation': 'Parunovic A. Floppy eyelid syndrome. Br J Ophthalmol. 1983 Apr;67(4):264-6. doi: 10.1136/bjo.67.4.264.'}, {'pmid': '6018907', 'type': 'BACKGROUND', 'citation': 'Brown IA. Ankyloblepharon associated with keratoconus. Br J Ophthalmol. 1967 Feb;51(2):138-9. doi: 10.1136/bjo.51.2.138. No abstract available.'}, {'pmid': '16303509', 'type': 'BACKGROUND', 'citation': 'Cristina Kenney M, Brown DJ. The cascade hypothesis of keratoconus. Cont Lens Anterior Eye. 2003 Sep;26(3):139-46. doi: 10.1016/S1367-0484(03)00022-5.'}, {'pmid': '3977705', 'type': 'BACKGROUND', 'citation': 'Scott AB, Kennedy RA, Stubbs HA. Botulinum A toxin injection as a treatment for blepharospasm. Arch Ophthalmol. 1985 Mar;103(3):347-50. doi: 10.1001/archopht.1985.01050030043017.'}, {'pmid': '16491229', 'type': 'BACKGROUND', 'citation': 'Schellini SA, Matai O, Igami TZ, Padovani CR, Padovani CP. [Essential blepharospasm and hemifacial spasm: characteristic of the patient, botulinum toxin A treatment and literature review]. Arq Bras Oftalmol. 2006 Jan-Feb;69(1):23-6. doi: 10.1590/s0004-27492006000100005. Epub 2006 Feb 10. Portuguese.'}, {'pmid': '21225137', 'type': 'BACKGROUND', 'citation': 'Nicoletti AG, Aoki L, Nahas TR, Matayoshi S. [Essential blepharospasm: literature review]. Arq Bras Oftalmol. 2010 Sep-Oct;73(5):469-73. doi: 10.1590/s0004-27492010000500018. Portuguese.'}, {'pmid': '20590421', 'type': 'BACKGROUND', 'citation': 'Coscarelli JM. Essential blepharospasm. Semin Ophthalmol. 2010 May;25(3):104-8. doi: 10.3109/08820538.2010.488564.'}, {'pmid': '9584238', 'type': 'BACKGROUND', 'citation': 'Krumeich JH, Daniel J, Knulle A. Live-epikeratophakia for keratoconus. J Cataract Refract Surg. 1998 Apr;24(4):456-63. doi: 10.1016/s0886-3350(98)80284-8.'}, {'pmid': '28591280', 'type': 'DERIVED', 'citation': 'Renesto ADC, Osaki TH, Osaki MH, Hirai FE, Campos M. Keratoconus progression is not inhibited by reducing eyelid muscular force with botulinum toxin A treatment: a randomized trial. Arq Bras Oftalmol. 2017 Mar-Apr;80(2):88-92. doi: 10.5935/0004-2749.20170022.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.gov', 'label': 'Pubmed comprises citations for biomedical literature from MEDLINE, life science journals, and online books.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to associate the use of botulinum toxin type A for patients with keratoconus to demonstrate that tension eyelid has an important role in disease progression.', 'detailedDescription': 'Subcutaneous injection of botulinum toxin type A will be performed at two points in a nasal and temporal extent of the orbicularis muscle of a group of patients with keratoconus (Botulinum toxin A group).The idea is to evaluate the change in palpebral fissure in patients from group botulinum toxin A over a period of 18 months.The measurements of the palpebral fissure will be performed by the Image J (version 1.34s) program, developed by the National Institutes of Health (USA).The unit of measure is the millimetre.The patients of the botulinum toxin A group will be compared with a control group, without any intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with documented keratoconus\n* best-corrected visual acuity measurable at refraction test\n* age between 10-40 years\n* good health\n* understand the procedure and its limitations\n\nExclusion Criteria:\n\n* only one functional eye\n* previous ocular surgery\n* concurrent corneal infection and other ocular diseases that modified the visual acuity\n* known allergy to botulinum toxin\n* pregnancy\n* poor collaboration for performing the examinations and the procedure'}, 'identificationModule': {'nctId': 'NCT01691651', 'briefTitle': 'Botulinum Toxin A for the Treatment of Keratoconus', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Botulinum Toxin Type A for Keratoconus', 'orgStudyIdInfo': {'id': 'RECUNIFESP-87051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum toxin type A', 'description': 'The group that will be subjected to the injection of botulinum toxin (subcutaneous injection of botulinum toxin type A).Subcutaneous botulinum toxin A injection will be performed in this group, (2.5 units per point application), at two points in a nasal and temporal extent of the orbicularis muscle.', 'interventionNames': ['Procedure: Subcutaneous injection of botulinum toxin type A', 'Drug: Botulinum Toxin Type A']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The group that will not be subjected to any intervention.'}], 'interventions': [{'name': 'Subcutaneous injection of botulinum toxin type A', 'type': 'PROCEDURE', 'description': 'Subcutaneous injection of botulinum toxin type A (2.5 units per application point) at two points in a nasal and temporal extent of the orbicularis muscle will be performed in the Botulinum toxin type A group.', 'armGroupLabels': ['Botulinum toxin type A']}, {'name': 'Botulinum Toxin Type A', 'type': 'DRUG', 'otherNames': ['Botox (Allergan)'], 'description': '2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.', 'armGroupLabels': ['Botulinum toxin type A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023-062', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of São Paulo, Department of Ophthalmology', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Adimara C Renesto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Teissy H Osaki, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Midori H Osaki, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Mauro Q Campos, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Adimara da Candelaria Renesto', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}