NCT07701265

Brief Summary

This study evaluated whether applying a compression dressing to one eyelid after upper eyelid blepharoplasty (eyelid lift surgery) reduces swelling, bruising, and discomfort compared to the untreated eyelid. In this randomized trial, each participant underwent bilateral upper eyelid blepharoplasty; after surgery, one eyelid was randomly assigned to receive a compression dressing for 24 hours, while the other eyelid received no dressing and served as the internal control. Outcomes including eyelid swelling, bruising, pain, aesthetic appearance, and corneal health were assessed by masked observers on postoperative days 1, 7, 30, and 90. The goal of this study was to determine whether routine use of compression dressing provides a measurable clinical benefit after this common cosmetic and functional eyelid surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 8, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

Upper eyelid blepharoplastyCompression dressingPostoperative edemaPostoperative ecchymosisSplit-eye designEyelid surgery

Outcome Measures

Primary Outcomes (2)

  • Postoperative eyelid edema

    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

    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 Outcomes (5)

  • Postoperative pain

    Postoperative day 1

  • Patient comfort

    Postoperative day 1

  • Corneal staining

    Postoperative days 1, 7, 30 and 90

  • Global aesthetic improvement

    Postoperative days 1, 7, 30 and 90

  • Best corrected visual acuity

    Baseline, postoperative days 1, 7, 30 and 90

Study Arms (2)

Compression Dressing (CD)

EXPERIMENTAL

Upper eyelid randomly assigned to receive a compression dressing (folded sterile gauze secured with elastic tape) for 24 hours after surgery.

Procedure: Compression Dressing (CD)

No Dressing (ND)

ACTIVE COMPARATOR

Contralateral upper eyelid receiving standard postoperative care without compression dressing, serving as the internal control.

Procedure: No Dressing (Standard Postoperative Care)

Interventions

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.

Compression Dressing (CD)

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.

No Dressing (ND)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beyoglu Eye Training and Research Hospital

Istanbul, Istanbul, 34421, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Postoperative edema, ecchymosis, and Global Aesthetic Improvement Scale scores were independently assessed by two masked investigators from standardized clinical photographs; disagreements were resolved by a third masked investigator. The masked assessors did not participate in surgery or dressing application and were unaware of side allocation.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study used a within-participant, split-eye design rather than a traditional temporal crossover. Each patient's two upper eyelids were simultaneously and randomly allocated (by coin toss) to receive either compression dressing or no dressing during the same surgical session, with the contralateral eyelid serving as the internal control, rather than each participant receiving both interventions sequentially over time.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ophthalmologist, Beyoglu Eye Training and Research Hospital

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

June 23, 2025

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations