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

January 10, 2011
January 10, 2011
May 1997
May 2010   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
skin irritation [ Designated as safety issue: Yes ]
was there a skin irritation after applicating the lead weight; yes or no
Same as current
Not Provided
Not Provided
 
External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note
External Lid Loading for the Temporary Treatment of the Paresis of the M. Orbicularis Oculi: a Clinical Note

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:

n.a.

Non-Probability Sample

patients with lagophthalmos due to surgery, central or peripheral paresis

  • Incomplete Closure of Lid
  • Parotis Tumor
  • m. Orbicularis Oculi Paresis
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.
cohort
cohort of consecutively enrolled patients with lagophthalmos
Intervention: Other: individually tailored lead weight
Müller-Jensen K, Müller-Jensen G. [Surgical and conservative treatment of lagophthalmus (facial paralysis). II]. Ophthalmologe. 1993 Feb;90(1):27-30. German.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
August 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01274689
NCT100111
No
Not Provided
Charite University, Berlin, Germany
Medical Park Berlin
Principal Investigator: Stefan Hesse, MD Charite - University Medicine Berlin, Medical Park Berlin
Charite University, Berlin, Germany
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP