Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-09-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Botulinum toxin type A
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.
Subcutaneous injection of botulinum toxin type A
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.
Botulinum Toxin Type A
2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.
Control
The group that will not be subjected to any intervention.
No interventions assigned to this group
Interventions
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Subcutaneous injection of botulinum toxin type A
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.
Botulinum Toxin Type A
2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* best-corrected visual acuity measurable at refraction test
* age between 10-40 years
* good health
* understand the procedure and its limitations
Exclusion Criteria
* previous ocular surgery
* concurrent corneal infection and other ocular diseases that modified the visual acuity
* known allergy to botulinum toxin
* pregnancy
* poor collaboration for performing the examinations and the procedure
10 Years
40 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Adimara da Candelaria Renesto
MD
Principal Investigators
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Adimara C Renesto, MD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Teissy H Osaki, MD
Role: STUDY_CHAIR
Federal University of São Paulo
Midori H Osaki, MD
Role: STUDY_CHAIR
Federal University of São Paulo
Mauro Q Campos, MD
Role: STUDY_DIRECTOR
Federal University of São Paulo
Locations
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Federal University of São Paulo, Department of Ophthalmology
São Paulo, São Paulo, Brazil
Countries
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References
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Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
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.
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.
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.
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.
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.
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.
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.
Parunovic A. Floppy eyelid syndrome. Br J Ophthalmol. 1983 Apr;67(4):264-6. doi: 10.1136/bjo.67.4.264.
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.
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.
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.
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.
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.
Coscarelli JM. Essential blepharospasm. Semin Ophthalmol. 2010 May;25(3):104-8. doi: 10.3109/08820538.2010.488564.
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.
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.
Related Links
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Pubmed comprises citations for biomedical literature from MEDLINE, life science journals, and online books.
Other Identifiers
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RECUNIFESP-87051
Identifier Type: -
Identifier Source: org_study_id
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