An evaluation of the safety and efficacy of botulinum toxin type A (BOTOX) when used to produce a protective ptosis

Abstract

Purpose: To evaluate the safety and efficacy of botulinum toxin type A (BOTOX, Allergan) when used to produce a protective ptosis in patients where a surgical tarsorrhaphy would otherwise be required.

Methods: A total of 21 patients entered into the study. Doses of 2.5 and 5.0 units of BOTOX were injected into the levator palpebrae superioris muscle through the eyelid. The patients were followed daily where practical until a ptosis developed and then monitored 1-2 weekly until the ptosis was resolved. Injections were repeated, if necessary until the underlying condition had healed.

Results: Ptosis took an average +/- SE of 4.0 +/- 0.5 days to develop (range 2-8 days). Duration of ptosis was an average +/- SE of 46.0 +/- 12.1 days (range 1-206 days). The effective dosage was 5 units of BOTOX in 0.1 mL. In 16 patients, the ptosis produced by BOTOX was sufficient to allow the underlying disease to heal and a surgical tarsorrhaphy was avoided. One patient required a surgical tarsorrhaphy and three patients required other surgical intervention to correct the underlying condition. One patient was lost to follow up. Diplopia was seen in five patients but resolved in all cases.

Conclusions: BOTOX was a suitable alternative to a surgical tarsorrhaphy.