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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Istanbul
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Istanbul, Istanbul, Turkije (Türkiye), 34421
- Beyoglu Eye Training and Research Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Compression Dressing (CD)
Upper eyelid randomly assigned to receive a compression dressing (folded sterile gauze secured with elastic tape) for 24 hours after surgery.
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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.
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Actieve vergelijker: No Dressing (ND)
Contralateral upper eyelid receiving standard postoperative care without compression dressing, serving as the internal control.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postoperative eyelid edema
Tijdsspanne: Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
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Standardized clinical photographs assessed by masked observers using a 5-point ordinal edema grading scale.
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Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
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Postoperative ecchymosis
Tijdsspanne: Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
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Standardized clinical photographs analysed using ImageJ software and graded by masked observers.
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Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative pain
Tijdsspanne: Postoperative day 1
|
Visual analogue scale (0-10)
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Postoperative day 1
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Patient comfort
Tijdsspanne: Postoperative day 1
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Patient questionnaire comparing comfort between the compression dressing and control eyelids.
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Postoperative day 1
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Corneal staining
Tijdsspanne: Postoperative days 1, 7, 30 and 90
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Fluorescein staining graded according to the Oxford grading scale.
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Postoperative days 1, 7, 30 and 90
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Global aesthetic improvement
Tijdsspanne: Postoperative days 1, 7, 30 and 90
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Global Aesthetic Improvement Scale assessed by masked observers using standardized clinical photographs.
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Postoperative days 1, 7, 30 and 90
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Best corrected visual acuity
Tijdsspanne: Baseline, postoperative days 1, 7, 30 and 90
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Best corrected visual acuity measured in logarithm of the minimum angle of resolution units.
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Baseline, postoperative days 1, 7, 30 and 90
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- BLF-25-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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