Dermatochalasis of Upper Eyelid
Conditions
Brief summary
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.
Interventions
PROCEDUREBlepharoplasty
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.
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall patient satisfaction | 3 months | Questionaire: FACE-Q eye module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FACE-Q eye module: individual questions | 3 months | Questionaire: FACE-Q eye module |
Countries
Austria
Outcome results
None listed