FACE-Q in Blepharoplasty

NCT04924972 | Completed DMC

• 1 other identifier: OPHTH-011018
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall patient satisfaction

  Questionaire: FACE-Q eye module

  3 months

Secondary Outcomes (1)

• FACE-Q eye module: individual questions

  3 months

Study Arms (2)

Intracutaneous Suture

Procedure: Blepharoplasty

running Suture

Procedure: Blepharoplasty

Interventions

Blepharoplasty 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.

Intracutaneous Suture; running Suture

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ninety patients will be enrolled in the study. Eligibility will be assessed at the first visit based on inclusion/exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Blepharoplasty

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Dermatologic Surgical Procedures; Plastic Surgery Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: June 14, 2021
• Study Start: February 1, 2019
• Primary Completion: July 13, 2022
• Study Completion: September 1, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)