- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07701265
Does Unilateral Compression Dressing Reduce Postoperative Swelling and Bruising After Upper Eyelid Blepharoplasty? (COMPRESS-BLEPH)
The Effect of Compression Dressing on Postoperative Outcomes After Upper Eyelid Blepharoplasty: A Randomized, Controlled, Observer-Blinded Evaluation Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a prospective, randomized, controlled, observer-masked, within-subject (split-eye) trial conducted at a single academic center between June and November 2025. Adult patients with bilateral dermatochalasis scheduled for upper eyelid blepharoplasty were enrolled. Following bilateral surgery performed by a single surgeon, one eyelid of each patient was randomly assigned by coin toss to receive a compression dressing (folded sterile gauze secured with elastic tape, left in place for 24 hours), while the contralateral eyelid received no dressing and served as the internal control. All patients received standardized postoperative care, including bilateral cold compresses and topical medications.
Two masked investigators independently assessed postoperative edema (5-point ordinal scale), ecchymosis (ImageJ-based area quantification), and aesthetic outcome (Global Aesthetic Improvement Scale) from standardized clinical photographs obtained on postoperative days 1, 7, 30, and 90; disagreements were resolved by a third masked investigator. Postoperative pain (visual analog scale) and patient comfort preference were recorded on day 1. Best corrected visual acuity and corneal fluorescein staining (Oxford grading scale) were assessed at each follow-up visit to evaluate ocular surface safety. Between-group comparisons were performed using the Wilcoxon signed-rank test, with Holm-Bonferroni correction applied across outcomes at each visit to account for multiple comparisons.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34421
- Beyoglu Eye Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients (≥18 years) with bilateral upper eyelid dermatochalasis scheduled for upper eyelid blepharoplasty
- Willingness and ability to provide written informed consent
- Ability to comply with the postoperative follow-up schedule (postoperative days 1, 7, 30, and 90)
Exclusion Criteria:
- History of prior upper eyelid surgery
- Unilateral dermatochalasis
- Previous eyelid trauma
- Congenital eyelid anomalies
- Blepharochalasis syndrome
- Coagulopathy
- Combined indication for ptosis repair and blepharoplasty
- Severe bilateral visual impairment precluding safe application of compression dressing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Compression Dressing (CD)
Upper eyelid randomly assigned to receive a compression dressing (folded sterile gauze secured with elastic tape) for 24 hours after surgery.
|
A compression dressing consisting of folded sterile gauze pads followed by a dry gauze layer, secured with elastic tape (Clivex®, Climed Healthcare, Türkiye), applied to one upper eyelid immediately after bilateral upper eyelid blepharoplasty and left in place for 24 hours.
The contralateral eyelid remained uncovered and undressed, serving as the internal control.
|
|
Active Comparator: No Dressing (ND)
Contralateral upper eyelid receiving standard postoperative care without compression dressing, serving as the internal control.
|
The contralateral upper eyelid received standard postoperative care without a compression dressing, remaining uncovered.
All other postoperative treatments (topical antibiotic ointment, cooling protocol, medications) were identical to the compression dressing side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative eyelid edema
Time Frame: Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
|
Standardized clinical photographs assessed by masked observers using a 5-point ordinal edema grading scale.
|
Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
|
|
Postoperative ecchymosis
Time Frame: Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
|
Standardized clinical photographs analysed using ImageJ software and graded by masked observers.
|
Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain
Time Frame: Postoperative day 1
|
Visual analogue scale (0-10)
|
Postoperative day 1
|
|
Patient comfort
Time Frame: Postoperative day 1
|
Patient questionnaire comparing comfort between the compression dressing and control eyelids.
|
Postoperative day 1
|
|
Corneal staining
Time Frame: Postoperative days 1, 7, 30 and 90
|
Fluorescein staining graded according to the Oxford grading scale.
|
Postoperative days 1, 7, 30 and 90
|
|
Global aesthetic improvement
Time Frame: Postoperative days 1, 7, 30 and 90
|
Global Aesthetic Improvement Scale assessed by masked observers using standardized clinical photographs.
|
Postoperative days 1, 7, 30 and 90
|
|
Best corrected visual acuity
Time Frame: Baseline, postoperative days 1, 7, 30 and 90
|
Best corrected visual acuity measured in logarithm of the minimum angle of resolution units.
|
Baseline, postoperative days 1, 7, 30 and 90
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BLF-25-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dermatochalasis of Upper Eyelid
-
Timothy EkhlassiCompletedPain | Dermatochalasis | Dermatochalasis of Eyelid | Dermatochalasis of Both Upper Eyelids | Dermatochalasis of Both Eyes | Dermatochalasis of Right Upper Eyelid | Dermatochalasis of Left Upper EyelidCanada
-
Osheru Inc.RecruitingPtosis, Eyelid | Blepharoplasty | Dermatochalasis of Upper EyelidUnited States
-
Medical University of ViennaCompleted
-
University of LouisvilleWithdrawnPtosis, Eyelid | Entropion | Ectropion | Dermatochalasis of EyelidUnited States
-
University of MiamiCompletedDermatochalasis | Eyelid DermatochalasisUnited States
-
Duke UniversityWithdrawnUse of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's SurgeryUpper Eyelid SurgeryUnited States
-
Wynand BWH Melenhorst, MDCompletedBlepharoplasty | Upper Eyelid BlepharoplastyNetherlands
-
Minia UniversityNot yet recruitingUpper Eyelid Dynamics
-
Augenklinik LMUCompletedDermatochalasis of EyelidGermany
-
University of California, San FranciscoUnknownEyelid Diseases | Ptosis, Eyelid | Blepharoptosis | Eyelid Tumor | Dermatochalasis | Entropion | Ectropion | Skin Cancer, Eyelid | Floppy Eyelid SyndromeUnited States
Clinical Trials on Compression Dressing (CD)
-
Florida Orthopaedic InstituteNuVasive; St. Louis UniversityTerminated
-
Augenklinik LMUCompletedDermatochalasis of EyelidGermany
-
Egyptian Biomedical Research NetworkCompletedChronic Venous Hypertension With UlcerEgypt
-
Rothman Institute OrthopaedicsCompleted
-
Solsys Medical LLCUnknownChronic Venous Hypertension With UlcerUnited States
-
Prisma Health-UpstateClemson University; BioDlogicsTerminatedVenous Insufficiency | Varicose UlcerUnited States
-
Liverpool Heart and Chest Hospital NHS Foundation...National Institute for Health Research, United Kingdom; Biolife LLC; The Johnson...TerminatedInjury; Blood Vessel, Wrist, Radial ArteryUnited Kingdom
-
Northwell HealthWithdrawnVenous Leg UlcerUnited States
-
Northumbria Healthcare NHS Foundation TrustUnknown
-
Hospital de Clinicas de Porto AlegreConselho Nacional de Desenvolvimento Científico e Tecnológico; Casex Innovation...Completed