Incomplete Closure of LidNCT01274689
External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note
An observational study of Incomplete Closure of Lid and Parotis Tumor, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The note re-introduces the external lid loading with the help of a lead weight for the temporary treatment of lagophthalmos. Although simple and effective, the technique is rarely used.Instead of wearing a monoculus, the patient uses an individually tailored lead weight (0.8 mm thickness, 1.0 -2.0 g) sticked on the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incomplete Closure of Lid, Parotis Tumor, m. Orbicularis Oculi Paresis
- What is being tested?
- individually tailored lead weight
- How many people
- 152 participants
- Where
- 1 siteGermany
- Study dates
- May 1997to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with lagophthalmos due to surgery, central or peripheral paresis
Who may be able to join
- lagophthalmos due to surgery, central or peripheral paresis able to understand the purpose of the study
Who cannot join
- skin irritations and/or open wounds in the area of the applied lead weight
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité University Medicine Berlin, Medical Park Berlin
Berlin, State of Berlin, 13507
About this study
The note re-introduces the external lid loading with the help of a lead weight for the temporary treatment of lagophthalmos. Although simple and effective, the technique is rarely used.Instead of wearing a monoculus, the patient uses an individually tailored lead weight (0.8 mm thickness, 1.0 -2.0 g) sticked on the lid, it enables its closure. A spontaneous ptosis indicates a too heavy weight. With the M. levator palpebrae intact, lid lifting is possible. The effect is gravity dependent, so that the patient has to wear the monoculus at night. To minimize the risk of lead intoxication, the surface of the weight is varnished. In case of a persistent paresis of the M. orbicularis oculi an internal lid loading can follow. A total of 152 lagophthalmos cases have been treated since 1997.All patients could close the lid immediately. Almost half of the patients had to re-adjust the weight several times per day due to hooded eyelids. The compliance was high, and a partial or complete restoration of the function of the M. orbicularis oculi occurred in 60% of the cases. In some subjects, the restoration of the M. orbicularis oculi was faster than of the M. orbicularis orbis. The external lid loading for the temporary treatment of lagophthalmos is simple and effective. Compared to a monoculus, the vision is unimpaired and the aesthetic is more appropriate for most patients. The faster restoration of the M. orbicularis oculi hints at a potentially facilitatory effect of the weight.
- Being tested
- individually tailored lead weight
- Keywords
- lagophthalmos, parotis tumor, m. orbicularis oculi paresis
- Medical subject headings
- Lagophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individually tailored lead weightOther
patients were treated with an individually tailored lead weight to train M. orbicularis oculi during day time
| Study group | Role | What they receive |
|---|---|---|
| cohort | cohort of consecutively enrolled patients with lagophthalmos Receives: Other: individually tailored lead weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
responder lid closure
responder was created, whether the lid closure was a) not possible, b) partially possible, c) completely possible
Secondary outcomes (1)
skin irritation
was there a skin irritation after applicating the lead weight; yes or no
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startMay 1997
- Primary completionMay 2010
- Study completionAug 2010
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 Incomplete Closure of LidStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Retrospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Park AG
- Investigators
- Stefan Hesse, MD, Principal investigator, Charite - University Medicine Berlin, Medical Park Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274689
- Sponsor's protocol ID
- NCT100111
- Status last verified
- Jun 2008
- First submitted
- 10 Jan 2011
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller-Jensen K, Muller-Jensen G. [Surgical and conservative treatment of lagophthalmus (facial paralysis). II]. Ophthalmologe. 1993 Feb;90(1):27-30. German.
PubMed 8443444
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note
- ClinicalTrials.gov ID
- NCT01274689
- Acronym / sponsor ID
- NCT100111
- Keywords
- lagophthalmos, parotis tumor, m. orbicularis oculi paresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Medical Park AG
- Study start
- May 1997
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Jan 2011 (estimated)
- 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 note re-introduces the external lid loading with the help of a lead weight for the temporary treatment of lagophthalmos. Although simple and effective, the technique is rarely used.Instead of wearing a monoculus, the patient uses an individually tailored lead weight (0.8 mm thickness, 1.0 -2.0 g) sticked on the lid, it enables its closure. A spontaneous ptosis indicates a too heavy weight. With the M. levator palpebrae intact, lid lifting is possible. The effect is gravity dependent, so that the patient has to wear the monoculus at night. To minimize the risk of lead intoxication, the surface of the weight is varnished. In case of a persistent paresis of the M. orbicularis oculi an internal lid loading can follow. A total of 152 lagophthalmos cases have been treated since 1997.All patients could close the lid immediately. Almost half of the patients had to re-adjust the weight several times per day due to hooded eyelids. The compliance was high, and a partial or complete restoration of the function of the M. orbicularis oculi occurred in 60% of the cases. In some subjects, the restoration of the M. orbicularis oculi was faster than of the M. orbicularis orbis. The external lid loading for the temporary treatment of lagophthalmos is simple and effective. Compared to a monoculus, the vision is unimpaired and the aesthetic is more appropriate for most patients. The faster restoration of the M. orbicularis oculi hints at a potentially facilitatory effect of the weight.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Other: individually tailored lead weightcohort of consecutively enrolled patients with lagophthalmos |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with lagophthalmos due to surgery, central or peripheral paresis
Key inclusion criteria (1 listed)
- lagophthalmos due to surgery, central or peripheral paresis able to understand the purpose of the study
Key exclusion criteria (1 listed)
- skin irritations and/or open wounds in the area of the applied lead weight
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 |
|---|---|---|
| individually tailored lead weightpatients were treated with an individually tailored lead weight to train M. orbicularis oculi during day time | Other | cohort |
Primary outcome
responder lid closure
responder was created, whether the lid closure was a) not possible, b) partially possible, c) completely possible
1 secondary outcome
skin irritation
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 11 Jan 2011.
- Background: PubMed 8443444Muller-Jensen K, Muller-Jensen G. [Surgical and conservative treatment of lagophthalmus (facial paralysis). II]. Ophthalmologe. 1993 Feb;90(1):27-30. German.
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.
Stefan Hesse, MD principal investigator
Charite - University Medicine Berlin, Medical Park Berlin
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 Incomplete Closure of Lid and Parotis Tumor, run by Charite University, Berlin, Germany 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 11 Jan 2011. 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?
responder lid closure. 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 NCT01274689, 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 11 Jan 2011.