Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm

Summary

A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal versus preseptal botulinum toxin for patients with eyelid spasm. The investigators hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will have greater clinical efficacy, better measured quality of life, fewer complications, and better cost effectiveness in comparison to a preseptal pattern of injection.

Timeline

Start

2015-07-01

Primary completion

2017-10-31

Completion

2019-02-20

Publications

• Background Jankovic J. Blepharospasm with basal ganglia lesions. Arch Neurol. 1986 Sep;43(9):866-8. doi: 10.1001/archneur.1986.00520090006004. No abstract available.
• Background Dutton JJ, Fowler AM. Botulinum toxin in ophthalmology. Surv Ophthalmol. 2007 Jan-Feb;52(1):13-31. doi: 10.1016/j.survophthal.2006.10.003.
• Background Czyz CN, Burns JA, Petrie TP, Watkins JR, Cahill KV, Foster JA. Long-term botulinum toxin treatment of benign essential blepharospasm, hemifacial spasm, and Meige syndrome. Am J Ophthalmol. 2013 Jul;156(1):173-177.e2. doi: 10.1016/j.ajo.2013.02.001. Epub 2013 Mar 28.
• Background Harrison AR, Erickson JP, Anderson JS, Lee MS. Pain relief in patients receiving periocular botulinum toxin A. Ophthalmic Plast Reconstr Surg. 2008 Mar-Apr;24(2):113-6. doi: 10.1097/IOP.0b013e31816386e1.
• Background Hilker R, Schischniaschvili M, Ghaemi M, Jacobs A, Rudolf J. Health related quality of life is improved by botulinum neurotoxin type A in long term treated patients with focal dystonia. J Neurol Neurosurg Psychiatry. 2001 Aug;71(2):193-9. doi: 10.1136/jnnp.71.2.193.
• Background Muller J, Wissel J, Kemmler G, Voller B, Bodner T, Schneider A, Wenning GK, Poewe W. Craniocervical dystonia questionnaire (CDQ-24): development and validation of a disease-specific quality of life instrument. J Neurol Neurosurg Psychiatry. 2004 May;75(5):749-53. doi: 10.1136/jnnp.2003.013441.
• Background Hall TA, McGwin G Jr, Searcey K, Xie A, Hupp SL, Owsley C, Kline LB. Health-related quality of life and psychosocial characteristics of patients with benign essential blepharospasm. Arch Ophthalmol. 2006 Jan;124(1):116-9. doi: 10.1001/archopht.124.1.116.
• Background Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
• Background Thenganatt MA, Fahn S. Botulinum toxin for the treatment of movement disorders. Curr Neurol Neurosci Rep. 2012 Aug;12(4):399-409. doi: 10.1007/s11910-012-0286-3.
• Background Huang W, Foster JA, Rogachefsky AS. Pharmacology of botulinum toxin. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):249-59. doi: 10.1067/mjd.2000.105567.
• Background Harrison AR. Chemodenervation for facial dystonias and wrinkles. Curr Opin Ophthalmol. 2003 Oct;14(5):241-5. doi: 10.1097/00055735-200310000-00003.
• Background Costa J, Espirito-Santo C, Borges A, Ferreira JJ, Coelho M, Moore P, Sampaio C. Botulinum toxin type A therapy for blepharospasm. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004900. doi: 10.1002/14651858.CD004900.pub2.
• Background Aramideh M, Ongerboer de Visser BW, Brans JW, Koelman JH, Speelman JD. Pretarsal application of botulinum toxin for treatment of blepharospasm. J Neurol Neurosurg Psychiatry. 1995 Sep;59(3):309-11. doi: 10.1136/jnnp.59.3.309.
• Background Jankovic J. Pretarsal injection of botulinum toxin for blepharospasm and apraxia of eyelid opening. J Neurol Neurosurg Psychiatry. 1996 Jun;60(6):704. doi: 10.1136/jnnp.60.6.704. No abstract available.
• Background Albanese A, Bentivoglio AR, Colosimo C, Galardi G, Maderna L, Tonali P. Pretarsal injections of botulinum toxin improve blepharospasm in previously unresponsive patients. J Neurol Neurosurg Psychiatry. 1996 Jun;60(6):693-4. doi: 10.1136/jnnp.60.6.693-a. No abstract available.
• Background Cakmur R, Ozturk V, Uzunel F, Donmez B, Idiman F. Comparison of preseptal and pretarsal injections of botulinum toxin in the treatment of blepharospasm and hemifacial spasm. J Neurol. 2002 Jan;249(1):64-8. doi: 10.1007/pl00007849.
• Background Albanese A, Sorbo FD, Comella C, Jinnah HA, Mink JW, Post B, Vidailhet M, Volkmann J, Warner TT, Leentjens AF, Martinez-Martin P, Stebbins GT, Goetz CG, Schrag A. Dystonia rating scales: critique and recommendations. Mov Disord. 2013 Jun 15;28(7):874-83. doi: 10.1002/mds.25579.
• Background Wabbels B, Jost WH, Roggenkamper P. Difficulties with differentiating botulinum toxin treatment effects in essential blepharospasm. J Neural Transm (Vienna). 2011 Jun;118(6):925-43. doi: 10.1007/s00702-010-0546-9. Epub 2011 Jan 9.
• Background Wabbels B, Roggenkamper P. Botulinum toxin in hemifacial spasm: the challenge to assess the effect of treatment. J Neural Transm (Vienna). 2012 Aug;119(8):963-80. doi: 10.1007/s00702-011-0762-y. Epub 2012 Jan 10.
• Background Sarifakioglu N, Sarifakioglu E. Evaluating effects of preservative-containing saline solution on pain perception during botulinum toxin type-a injections at different locations: a prospective, single-blinded, randomized controlled trial. Aesthetic Plast Surg. 2005 Mar-Apr;29(2):113-5. doi: 10.1007/s00266-004-0062-0. Epub 2005 Apr 14.
• Background Jankovic J, Kenney C, Grafe S, Goertelmeyer R, Comes G. Relationship between various clinical outcome assessments in patients with blepharospasm. Mov Disord. 2009 Feb 15;24(3):407-13. doi: 10.1002/mds.22368.
• Background Marcet MM, Lemke BN, Greenwald MJ, Fountain TR, Roth S, Dubovy SR. Eyelid eversion for visualisation of the upper eyelid lamellae: an anatomical cadaver study. Br J Ophthalmol. 2011 Oct;95(10):1376-8. doi: 10.1136/bjophthalmol-2011-300020. Epub 2011 Jul 11.
• Background Marcet MM, Meyer DR, Greenwald MJ, Roth S, Selva D. Proximal tarsal attachments of the levator aponeurosis: implications for blepharoptosis repair. Ophthalmology. 2013 Sep;120(9):1924-9. doi: 10.1016/j.ophtha.2013.02.012. Epub 2013 Apr 16.

Drugs

Indications