FACE-Q in Blepharoplasty

NCT ID: NCT04924972

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-09-01

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.

Conditions

Dermatochalasis of Upper Eyelid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intracutaneous Suture

Blepharoplasty

Intervention Type: PROCEDURE

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.

running Suture

Blepharoplasty

Intervention Type: PROCEDURE

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.

Interventions

Blepharoplasty

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Reinhard Told

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

OPHTH-011018

Identifier Type: -

Identifier Source: org_study_id