Skip to main content
OpenTrials
Completed

NCT Number: NCT04924972

FACE-Q in Blepharoplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dermatochalasis of Upper Eyelid

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Overall patient satisfaction

    Time frame: 3 months

    Questionaire: FACE-Q eye module

Secondary outcomes

  1. FACE-Q eye module: individual questions

    Time frame: 3 months

    Questionaire: FACE-Q eye module

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2021
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.