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临床试验/NCT07701265
NCT07701265已完成不适用

The Effect of Compression Dressing on Postoperative Outcomes After Upper Eyelid Blepharoplasty: A Randomized, Controlled, Observer-Blinded Evaluation Study

Fatma Poslu Karademir1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年6月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Postoperative eyelid edema

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Compression Dressing (CD) (Procedure)

No Dressing (ND)

Active Comparator

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

干预措施: No Dressing (Standard Postoperative Care) (Procedure)

结局指标

主要结局

Postoperative eyelid edema

时间窗: 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 ecchymosis

时间窗: Postoperative day 1, postoperative day 7, postoperative day 30, postoperative day 90

Standardized clinical photographs analysed using ImageJ software and graded by masked observers.

次要结局

  • 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)

研究者

发起方
Fatma Poslu Karademir
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Fatma Poslu Karademir

Ophthalmologist, Beyoglu Eye Training and Research Hospital

Beyoglu Eye Research and Education Hospital

研究点 (1)

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