N/A
N=264
Silicone Gel for Postsurgical Scars of the Eyelid
Scarring Due to Treatment
Bottom Line
View on ClinicalTrials.gov: NCT03601247 ↗Enrolled (actual)
264
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Post-operative Scarring - Erythema — 1.67; 1.70; 1.50; 1.65 score on a scale — p=0.48
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- silicone gel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Scarring - Erythema |
1.67; 1.70; 1.50; 1.65; 1.32; 1.37 | 0.48 |
| PRIMARY Post-operative Scarring - Elevation |
1.50; 1.48; 1.38; 1.29; 1.11; 1.11 | 1.00 |
| PRIMARY Post-operative Scarring - Pigmentation |
1.48; 1.50; 1.44; 1.47; 1.22; 1.16 | 1.00 |
| SECONDARY Patient Satisfaction |
3.87; 3.94; 4.00; 4.00; 4.21; 4.26 | 0.33 |
| SECONDARY Post-operative Itching |
1.69; 1.72; 1.41; 1.35; 1.21; 1.26 | 0.53 |
| SECONDARY Post-Operative Pain |
1.11; 1.09; 1.09; 1.06; 1.00; 1.05 | 0.77 |
| SECONDARY Patient Scar Preference |
13; 11; 30; 7; 16; 11 | — |
Summary
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
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
- Had prior eyelid surgery
- Undergoing additional upper eyelid surgery
- Using topical treatments on the upper eyelids that would interfere with the investigation
Data sourced from ClinicalTrials.gov (NCT03601247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.