External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note

This study has been completed.
Sponsor:
Collaborator:
Medical Park Berlin
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01274689
First received: January 10, 2011
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Incomplete Closure of Lid
Parotis Tumor
m. Orbicularis Oculi Paresis
Other: individually tailored lead weight

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • responder lid closure [ Designated as safety issue: No ]
    responder was created, whether the lid closure was a) not possible, b) partially possible, c) completely possible


Secondary Outcome Measures:
  • skin irritation [ Designated as safety issue: Yes ]
    was there a skin irritation after applicating the lead weight; yes or no


Biospecimen Retention:   None Retained

n.a.


Estimated Enrollment: 152
Study Start Date: May 1997
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cohort
cohort of consecutively enrolled patients with lagophthalmos
Other: individually tailored lead weight
patients were treated with an individually tailored lead weight to train M. orbicularis oculi during day time
Other Name: n.a.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with lagophthalmos due to surgery, central or peripheral paresis

Criteria

Inclusion Criteria:

  • lagophthalmos due to surgery, central or peripheral paresis able to understand the purpose of the study

Exclusion Criteria:

  • skin irritations and/or open wounds in the area of the applied lead weight
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01274689

Locations
Germany
Charité University Medicine Berlin, Medical Park Berlin
Berlin, Germany, 13507
Sponsors and Collaborators
Charite University, Berlin, Germany
Medical Park Berlin
Investigators
Principal Investigator: Stefan Hesse, MD Charite - University Medicine Berlin, Medical Park Berlin
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01274689     History of Changes
Other Study ID Numbers: NCT100111
Study First Received: January 10, 2011
Last Updated: January 10, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
lagophthalmos
parotis tumor
m. orbicularis oculi paresis

Additional relevant MeSH terms:
Paresis
Muscle Weakness
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014