Paralysis of the Orbicularis Muscle of the Eye in the Treatment for Dry Eye
Summary
This is a prospective, comparative, contralateral eye study. Patients older than 18 years who have had treatment with topical lubricants for at least 1 month and persist with symptoms of dry eye and corneal staining with fluorescein were included. Patients with dry eye attributable to abnormalities of the eyelids, nasolacrimal obstruction and active corneal infection, as well as patients with severe dry eye were excluded from the study. One eye randomly received a subcutaneous injection of botulinum toxin in the medial part of the lower eyelid, and the other eye received a similar procedure with placebo. The subjective evaluation was achieved with a questionnaire assessing symptoms of dry eye and conjunctivitis, quality of vision and ocular comfort level each eye separately. The objective evaluation included the measurement of the tear film break up time, Schirmer's test and with a modification of the Oxford grading scheme for corneal and conjunctival staining.
Timeline
- Start
- 2013-05
- Primary completion
- 2014-02
- Completion
- 2015-01
Publications
- Background The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
- Background Horwath-Winter J, Bergloeff J, Floegel I, Haller-Schober EM, Schmut O. Botulinum toxin A treatment in patients suffering from blepharospasm and dry eye. Br J Ophthalmol. 2003 Jan;87(1):54-6. doi: 10.1136/bjo.87.1.54.
- Background Sahlin S, Chen E, Kaugesaar T, Almqvist H, Kjellberg K, Lennerstrand G. Effect of eyelid botulinum toxin injection on lacrimal drainage. Am J Ophthalmol. 2000 Apr;129(4):481-6. doi: 10.1016/s0002-9394(99)00408-0.
- Background Reifler DM. Early descriptions of Horner's muscle and the lacrimal pump. Surv Ophthalmol. 1996 Sep-Oct;41(2):127-34. doi: 10.1016/s0039-6257(96)80002-6.
- Background Kakizaki H, Zako M, Miyaishi O, Nakano T, Asamoto K, Iwaki M. The lacrimal canaliculus and sac bordered by the Horner's muscle form the functional lacrimal drainage system. Ophthalmology. 2005 Apr;112(4):710-6. doi: 10.1016/j.ophtha.2004.11.043.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 4 iu | Subcutaneous |