Other Degenerative Disorders of Eyelid and Periocular Area Clinical Trial
Official title:
Botulinum Toxin to Improve Lower Blepharoplasty Scar
The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle)
and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty
incision whereas the scar is more visible on patient.
The main aim of this trial is to investigate whether the injection of Botulinum toxin into
the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower
blepharoplasty.
The main aim of this double blind randomized trial is to examine whether immediate
post-operative injection of botulinum toxin into lateral part of bilateral orbicularis
oculis muscles (the injection technique of crow feet) can improve scar formation for lower
blepharoplasty patients.
This is a double blind randomized controlled trial primarily designed to compare the
scarring after secondary cleft lip repair with immediate post-operative botulinum toxin
injection into the into bilateral lateral orbicularis oculi muscles in patients with lower
blepharoplasty. There will be 2 main groups in this study:-
1. Study group (Group I): Immediately after lower blepharoplasty surgery 3 injections of
2.5U of botulinum toxin over lateral part of orbicularis oculi muscle.
2. Control group (Group II): There will be the same amount of normal saline injection
after lower blepharoplasty.
Follow-up Assessments Vancouver scar scale measures pigmentation, vascularity, pliability
and scar height on the postoperative 6 month Follow Up.
Visual analogue scale They were asked to score the scars on the photographs using a standard
visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).
Photographic measurement:
A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can
be measured.
Chi-square will be used to analyze the demographic data ( i.e. Gender) The Independent
T-Student test will be used to analyze the statistical significance between the two groups.
The dosage of Botox that the investigators use for crowfeet is very tiny. And this is a
common clinic practice. Systemic insult is unlikely to happen. If an allergic reaction
occurred it will be treated according to the severity of allergy and Diphenhydramin PO or IV
form or systemic corticosteroid will be given.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention