Other Degenerative Disorders of Eyelid and Periocular Area
Conditions
Keywords
Lower blepharoplasty, Botulinum toxin, Scar
Brief summary
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.
Detailed description
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.
Interventions
DRUGBotulinum Toxin
A total of 7.5U per side of botulinum toxin will be injected to the lateral part of obicularis oculis muscle (3 injections of 2.5 U).
OTHERNormal Saline
The same amount (3 cc) of Normal saline will be injected to the lateral part of obicularis oculis muscle
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult ≥ 45 years old. 2. Lower eyelid Rhytidosis and dermatochalasis. 3. Lower eyelid steatoblepharon and pronounced nasojugal groove 4. Written informed consent given by patient.
Exclusion criteria
1. Less than 45 years old 2. Without written informed consent. 3. Combined other craniofacial anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | 6 months after surgery | to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver scar scale | 6 months after surgery | Use vancouver scar scale to access the scar of blepharoplasty |
| Photographic measurement | 6 months after surgery | A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured |
Countries
Taiwan
Contacts
Primary ContactChun Shin Chang, M.S.
Outcome results
None listed