Ptosis, EyelidNCT05770973
Effect of Eyelid Patching After Ptosis Surgery
A study testing Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany in people with Ptosis, Eyelid, run by Augenklinik LMU at 1 site in Germany.
Trial summary
The goal of this randomized, controlled, observer-blinded study is to compare the effect of compression dressing after ptosis surgery. The main question it aims to answer are: Effect of dressing on edema, hematoma, scar formation, ocular surface irritation and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ptosis, Eyelid
- What is being tested?
- Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 1 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ptosis
Who cannot join
- kongenital ptosis, pre-surgery, trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Eyelid Patching After Anterior Lector Reinsertion and Blepharoplasty on Edema, Hematoma, Scar Formation and Ocular Surface Irritation
The goal of this randomized, controlled, observer-blinded study is to compare the effect of compression dressing after ptosis surgery.
The main question it aims to answer are:
Effect of dressing on edema, hematoma, scar formation, ocular surface irritation and postoperative pain.
Patients are randomized after surgery for compression dressing or not. Results are scored by a blinded observer.
type of study: clinical trial
- Conditions
- Ptosis, Eyelid
- Being tested
- Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany
- Keywords
- Ptosis, Blepharoplasty, Eyelid surgery
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, GermanyOther
Compression dressing after ptosis surgery
| Study group | Role | What they receive |
|---|---|---|
| Compression dressing | Active comparator | Randomized, eyes were patched with a compression dressing after surgery. Receives: Other: Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany |
| No Compression dressing | No intervention | Randomized, eyes were not patched with a dressing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematoma
degree of hematoma postoperatively. Ranked by a blinded observer on a four point rating scale (0=none, 1=mild, 2=moderate, 3=severe) using phtographies of the patients eyes.
Measured: First postoperative day until 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jul 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ptosis, 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
- randomized for compression dressing or none
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augenklinik LMU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Schuh, Principal investigator, Augenklinik LMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770973
- Sponsor's protocol ID
- 20-304
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Date will be shared on request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eyelid Patching After Anterior Lector Reinsertion and Blepharoplasty on Edema, Hematoma, Scar Formation and Ocular Surface Irritation
- ClinicalTrials.gov ID
- NCT05770973
- Acronym / sponsor ID
- 20-304
- Conditions
- Ptosis, Eyelid
- Keywords
- Ptosis, Blepharoplasty, Eyelid surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Augenklinik LMUUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 16 Mar 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.
The goal of this randomized, controlled, observer-blinded study is to compare the effect of compression dressing after ptosis surgery.
The main question it aims to answer are:
Effect of dressing on edema, hematoma, scar formation, ocular surface irritation and postoperative pain.
Patients are randomized after surgery for compression dressing or not. Results are scored by a blinded observer.
type of study: clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomized for compression dressing or none
| Arm | Type | Receives |
|---|---|---|
| Compression dressing | Active comparator | Other: Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, GermanyRandomized, eyes were patched with a compression dressing after surgery. |
| No Compression dressing | No intervention | –Randomized, eyes were not patched with a dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ptosis
Key exclusion criteria (1 listed)
- kongenital ptosis, pre-surgery, trauma
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 dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, GermanyCompression dressing after ptosis surgery | Other | Compression dressing |
Primary outcome
hematoma
Time frame: First postoperative day until 8 weeks after surgery
degree of hematoma postoperatively. Ranked by a blinded observer on a four point rating scale (0=none, 1=mild, 2=moderate, 3=severe) using phtographies of the patients eyes.
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 16 Mar 2023.
- Individual participant dataSharing planned: No. Date will be shared on 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.
Anna Schuh principal investigator
Augenklinik LMU
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 (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany in people with Ptosis, 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 16 Mar 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?
hematoma (time frame: First postoperative day until 8 weeks after surgery). 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 16 Mar 2023.