Dermatochalasis of Upper EyelidNCT04924972
FACE-Q in Blepharoplasty
An observational study of Dermatochalasis of Upper Eyelid, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatochalasis of Upper Eyelid
- What is being tested?
- Blepharoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2019to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ninety patients will be enrolled in the study. Eligibility will be assessed at the first visit based on inclusion/exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Blepharoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlepharoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracutaneous Suture | Not described Receives: Procedure: Blepharoplasty | |
| running Suture | Not described Receives: Procedure: Blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient satisfaction
Questionaire: FACE-Q eye module
Measured: 3 months
Secondary outcomes (1)
FACE-Q eye module: individual questions
Questionaire: FACE-Q eye module
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Feb 2019
- Primary completion13 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatochalasis of Upper EyelidStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinhard Told, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924972
- Sponsor's protocol ID
- OPHTH-011018
- Status last verified
- Sep 2022
- First submitted
- 6 Aug 2019
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04924972
- Acronym / sponsor ID
- OPHTH-011018
- Conditions
- Dermatochalasis of Upper Eyelid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracutaneous Suture | – | Procedure: Blepharoplasty |
| running Suture | – | Procedure: Blepharoplasty |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ninety patients will be enrolled in the study. Eligibility will be assessed at the first visit based on inclusion/exclusion criteria.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blepharoplasty90 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. | Procedure or surgery | Intracutaneous Suture, running Suture |
Primary outcome
Overall patient satisfaction
Time frame: 3 months
Questionaire: FACE-Q eye module
1 secondary outcome
FACE-Q eye module: individual questions
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatochalasis of Upper Eyelid, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall patient satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.