Silicone Gel for Postsurgical Scars of the Eyelid

Not Applicable

Completed

• Conditions: Scarring Due to Treatment
• Interventions: Device: silicone gel

• Registration Number: NCT03601247
• Lead Sponsor: Montefiore Medical Center

Brief Summary

To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.

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.

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Study Start: 2018-08-01
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	silicone gel	Split-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel.

Primary Outcome Measures

Name	Time	Method
The appearance of post-operative scarring as graded by a blinded third-party physician using a questionnaire	2 years	To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.

Secondary Outcome Measures

Name	Time	Method
Rates of patient satisfaction with their post-operative scars as assessed by a questionnaire	2 years	To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States