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Completed

NCT Number: NCT03601247

Silicone Gel for Postsurgical Scars of the Eyelid

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

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Key information

Conditions

Scarring Due to Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Had prior eyelid surgery
  • Undergoing additional upper eyelid surgery
  • Using topical treatments on the upper eyelids that would interfere with the investigation

Treatment and study plan

silicone gel

Device

Patients who have consented to the study will receive two tubes labeled only "left" and "right", corresponding to the side of the face to which the tube contents will be applied. One tube will contain silicone gel and the other tube will contain aquaphor. Neither the patient nor the surgeon will know what side will receive which treatment. These tubes will be given to patients at post-operative week 1 visit. Patients will be instructed to rub the solution into their eyelid incisions gently with their fingers for 2-3 minutes twice a day

Primary outcomes

  1. Post-operative Scarring - Erythema

    Time frame: Up to 6 months post-operation

    To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness.

  2. Post-operative Scarring - Elevation

    Time frame: Up to 6 months post-operation

    To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (<0.5 mm)", and "3=definite elevation (>0.5 mm)". Higher mean scores are associated with increased elevation.

  3. Post-operative Scarring - Pigmentation

    Time frame: 6 months post-operation

    To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: Up to 6 months post-operation

    To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars patient satisfaction with post-operative scars was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via a questionnaire. Patients could choose between "1=very dissatisfied", "2=dissatisfied", "3=neutral", "4=satisfied", "5=very satisfied."

  2. Post-operative Itching

    Time frame: Up to 6 months post-operation

    Post-operative Itching was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medication". Higher mean scores are associated with increased itching.

  3. Post-Operative Pain

    Time frame: Up to 6 months post-operation

    Post-operative Pain was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medical attention". Higher mean scores are associated with increased pain.

  4. Patient Scar Preference

    Time frame: 6 months post-operation

    To determine whether silicone gel treatment has any effect on patient preference of post-surgical eyelid scar treatment, patient preference with scars at 1 week, 1 month, and 6 months post-operation was assessed by a questionnaire. Blinded patients could choose "right" or "left" or "neither". Non-blinded coders then converted patient responses to "Silicone Gel treatment preferred" or "Placebo treatment preferred" or "Neither treatment preferred" based on each patient's eye randomization. The number of patients in each categorical variable is summarized by study arm.

Other outcomes

  1. Post-operative Firmness

    Time frame: Up to 6 months post-operation

    Post-operative scar firmness was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=normal or soft/supple" and "2=hard". Higher mean scores are associated with increased firmness.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2018
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.