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

NCT01274689 | Completed

• 1 other identifier: NCT100111
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Incomplete Closure of Lid; Parotis Tumor; m. Orbicularis Oculi Paresis

Keywords

lagophthalmos; parotis tumor; m. orbicularis oculi paresis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cohort

cohort of consecutively enrolled patients with lagophthalmos

Other: individually tailored lead weight

Interventions

individually tailored lead weight OTHER

patients were treated with an individually tailored lead weight to train M. orbicularis oculi during day time

cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with lagophthalmos due to surgery, central or peripheral paresis

You may qualify if:

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

You may not qualify if:

• skin irritations and/or open wounds in the area of the applied lead weight

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Medical Park AG: collaborator

Study Sites (1)

Charité University Medicine Berlin, Medical Park Berlin

Berlin, State of Berlin, 13507, Germany

Location

Related Publications (1)

• Muller-Jensen K, Muller-Jensen G. [Surgical and conservative treatment of lagophthalmus (facial paralysis). II]. Ophthalmologe. 1993 Feb;90(1):27-30. German.

  PMID: 8443444 BACKGROUND

MeSH Terms

Conditions

Lagophthalmos

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Eyelid Diseases

Study Officials

• Stefan Hesse, MD

  Charite - University Medicine Berlin, Medical Park Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 11, 2011
• Study Start: May 1, 1997
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 11, 2011

Record last verified: 2008-06

Locations

DE (1)