Silicone Gel for Postsurgical Scars of the Eyelid

Brief Summary
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
Brief Title
Silicone Gel for Postsurgical Scars of the Eyelid
Detailed Description
Upper eyelid blepharoplasty or ptosis repair is performed when the upper eyelid becomes droopy, which often occurs as a natural part of the aging process. The droopiness of the upper eyelids decreases the ability to see objects in their peripheral vision, causing functional deficits. Additionally, the droopiness can be a cosmetic concern for many. The most effective treatment option is blepharoplasty or ptosis repair.

During routine pre-operative counseling, many patients note a fear of prominent facial scarring. Different techniques have been described in the literature to minimize scarring, from steroid creams to injections to laser therapy; however, there is currently no consensus for long-term management of post-surgical eyelid scars. Specifically, there is no study examining the efficacy of topical silicone gel on eyelid scars, although a few studies have examined its efficacy on other facial scars. Silicone is proposed to aid in healing by regulating fibroblast production, reducing collagen production, and modifying expression of growth factors.

The investigator's study is designed to determine whether topical silicone may prevent significant post-operative eyelid scar formation. It may help clarify whether there is a safe and effective topical treatment for patients undergoing eyelid surgery for whom scarring or cosmesis is a concern. It is the first study of silicone gel on the eyelid and is also prospective, randomized, and double blinded.
Completion Date
Completion Date Type
Actual
Conditions
Scarring Due to Treatment
Eligibility Criteria
Inclusion Criteria:

* Patients will be included if they have met the criteria for undergoing upper eyelid ptosis repair or blepharoplasty. This means they have droopiness of the upper eyelids that is visually significant and limiting the patient's visual field.

Exclusion Criteria:

* Patients will be excluded if they require additional upper eyelid surgery.
Inclusion Criteria
Inclusion Criteria:

* Patients will be included if they have met the criteria for undergoing upper eyelid ptosis repair or blepharoplasty. This means they have droopiness of the upper eyelids that is visually significant and limiting the patient's visual field.

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03601247
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9074
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid
Primary Outcomes
Outcome Description
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
Outcome Measure
The appearance of post-operative scarring as graded by a blinded third-party physician using a questionnaire
Outcome Time Frame
2 years
Secondary Outcomes
Outcome Description
To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars.
Outcome Time Frame
2 years
Outcome Measure
Rates of patient satisfaction with their post-operative scars as assessed by a questionnaire
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Anne Barmettler
Investigator Email
abarmett@montefiore.org