FACE-Q in Blepharoplasty

Medical University of Vienna

Status: Completed

Conditions: Dermatochalasis of Upper Eyelid

Treatments: Procedure: Blepharoplasty

Study type: Observational

Funder types: Other

Identifiers

NCT04924972

OPHTH-011018

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

90 participants in 2 patient groups

Intracutaneous Suture

Treatment:

Procedure: Blepharoplasty

running Suture

Treatment:

Procedure: Blepharoplasty