FACE-Q in Blepharoplasty
Face-Q Patient-Report Assisted Subjective and Objective Evaluation of Upper Eye Lid Blepharoplasty Outcomes Using Different Suturing Techniques: A Randomized Observer and Patient-Blinded Pilot Study
The aim of this study is to assess the effect of two different suturing techniques in patients undergoing bilateral upper eyelid blepharoplasty on the results of the FACE-Q Eye Module questionnaire for measuring patient-reported outcomes as well as on the blinded objective assessment by two experienced surgeons using the same questionnaire.
We aim to investigate the differences of the 2 most common techniques of skin closure with running cutaneous or subcuticular Nylon (6-0 Prolene) sutures in upper blepharoplasties and their effect on postoperative complications and scar formation. Besides the functional outcomes (visual field) and objective postoperative results, we aim to measure the patients' satisfaction using the FACE-Q Eye Module as a comprehensive, procedure- and disease-specific patient-reported outcome instrument.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Vienna、奥地利、1090
- Medical University of Vienna
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion criteria
- Women and men between 18-99 years
- With bilateral dermatochalasis and resulting visual field restriction
- Willingness and ability to comply with regular visits
- Signed informed consent form
Exclusion criteria
- Any disease affecting wound closure/healing such as diabetes, connective tissue disease or non-medically induced bleeding disorders, known autoimmune disease, known tendency for hypertrophic scars or keloids;
- Untreated hypertension or metabolic syndrome,
- Smoker
- Asymmetric brow ptosis,
- Previous surgery on the eye lids
- Sequelae after facial nerve palsy
- Allergy or adverse reaction to any substance or material used.
- Active or chronic eyelid inflammation
Pregnant or breast-feeding women:
Women of childbearing potential (18-50) are not excluded form this study. Breastfeeding or pregnant women are however excluded, as bilateral upper eye lid blepharoplasty can be easily postponed.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Intracutaneous Suture
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90 patients undergoing bilateral upper eyelid blepharoplasty are randomly assigned to a suturing technique (running cutaneous or subcuticular Nylon (6-0 Prolene) sutures).
Steri-strips will be used until suture removal 7 days after blepharoplasty for patient blinding.
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running Suture
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90 patients undergoing bilateral upper eyelid blepharoplasty are randomly assigned to a suturing technique (running cutaneous or subcuticular Nylon (6-0 Prolene) sutures).
Steri-strips will be used until suture removal 7 days after blepharoplasty for patient blinding.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall patient satisfaction
大体时间：3 months
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Questionaire: FACE-Q eye module
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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FACE-Q eye module: individual questions
大体时间：3 months
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Questionaire: FACE-Q eye module
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3 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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