- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Istanbul
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Istanbul, Istanbul, Turquie (Türkiye), 34421
- Beyoglu Eye Training and Research Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative eyelid edema
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain
Délai: Postoperative day 1
|
Visual analogue scale (0-10)
|
Postoperative day 1
|
|
Patient comfort
Délai: Postoperative day 1
|
Patient questionnaire comparing comfort between the compression dressing and control eyelids.
|
Postoperative day 1
|
|
Corneal staining
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- BLF-25-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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