Dermatochalasis of EyelidNCT06111170
Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain and Ocular Surface Irritation
A study testing Compression dressing in people with Dermatochalasis of Eyelid, run by Augenklinik LMU at 1 site in Germany.
Trial summary
Study to analyze whether there is a difference in postoperative outcome regarding edema, ecchymosis, pain, OSI and discomfort of the patients after blepharoplasty if a compression dressing is used or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatochalasis of Eyelid
- What is being tested?
- Compression dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to 1 May 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with upper eyelid dermatochalasis who were scheduled for upper eyelid blepharoplasty
Who cannot join
- previous surgery on the upper eyelid, previous eye lid trauma, congenital lid changes, blepharochalasis syndrome, coagulation disorders or indication for combined ptosis and blepharoplasty surgery
Trial locations and contacts
1 site in 1 country.
About this study
Study to analyze whether there is a difference in postoperative outcome regarding edema, ecchymosis, pain, OSI and discomfort of the patients after blepharoplasty if a compression dressing is used or not.
- Conditions
- Dermatochalasis of Eyelid
- Being tested
- Compression dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression dressingDevice
Application of dressing
| Study group | Role | What they receive |
|---|---|---|
| Compression dressing | Active comparator | Compression dressing was applied to one of the eyelids which was chosen by randomization postoperatively Receives: Device: Compression dressing |
| no dressing | No intervention | No dressing was applied on the other eyelid (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema
Degree of edema postoperatively, rated on a four point rating scale: 0 = no, 1 = minimal, 2 = moderate, 3 = severe
Measured: Measures are taken the first day after surgery (D1), one week after surgery (D7) and eight weeks after surgery (D56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Dec 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatochalasis of EyelidStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arms. After randomization one eyelid of each patient was applied with a compression dressing, the other eyelid not.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augenklinik LMU
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Schuh, Augenklinik LMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111170
- Sponsor's protocol ID
- 20-305
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from the corresponding author, \[A.S.\], upon reasonable request
Publications
Schuh A, Reischmann L, Hintschich CR. Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain, and Ocular Surface Irritation. Ophthalmic Plast Reconstr Surg. 2024 Nov-Dec 01;40(6):627-633. doi: 10.1097/IOP.0000000000002666. Epub 2024 Apr 11.
PubMed 38624150
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain and Ocular Surface Irritation
- ClinicalTrials.gov ID
- NCT06111170
- Acronym / sponsor ID
- 20-305
- Conditions
- Dermatochalasis of Eyelid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Augenklinik LMUUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 1 Nov 2023 (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.
Study to analyze whether there is a difference in postoperative outcome regarding edema, ecchymosis, pain, OSI and discomfort of the patients after blepharoplasty if a compression dressing is used or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- two arms. After randomization one eyelid of each patient was applied with a compression dressing, the other eyelid not.
| Arm | Type | Receives |
|---|---|---|
| Compression dressing | Active comparator | Device: Compression dressingCompression dressing was applied to one of the eyelids which was chosen by randomization postoperatively |
| no dressing | No intervention | –No dressing was applied on the other eyelid (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with upper eyelid dermatochalasis who were scheduled for upper eyelid blepharoplasty
Key exclusion criteria (1 listed)
- previous surgery on the upper eyelid, previous eye lid trauma, congenital lid changes, blepharochalasis syndrome, coagulation disorders or indication for combined ptosis and blepharoplasty surgery
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 |
|---|---|---|
| Compression dressingApplication of dressing | Device | Compression dressing |
Primary outcome
Edema
Time frame: Measures are taken the first day after surgery (D1), one week after surgery (D7) and eight weeks after surgery (D56)
Degree of edema postoperatively, rated on a four point rating scale: 0 = no, 1 = minimal, 2 = moderate, 3 = severe
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 1 Nov 2023.
- Derived from this study: PubMed 38624150Schuh A, Reischmann L, Hintschich CR. Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain, and Ocular Surface Irritation. Ophthalmic Plast Reconstr Surg. 2024 Nov-Dec 01;40(6):627-633. doi: 10.1097/IOP.0000000000002666. Epub 2024 Apr 11.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from the corresponding author, [A.S.], upon reasonable request
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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?
A study testing Compression dressing in people with Dermatochalasis of Eyelid, run by Augenklinik LMU at 1 site in Germany.
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 1 inclusion and 1 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 1 Nov 2023. 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 Germany. 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?
Edema (time frame: Measures are taken the first day after surgery (D1), one week after surgery (D7) and eight weeks after surgery (D56)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06111170, which also lists 1 linked publication.
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 1 Nov 2023.