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

NCT ID: NCT01274689

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1997-05-31
• Study Completion Date: 2010-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

cohort

cohort of consecutively enrolled patients with lagophthalmos

individually tailored lead weight

Intervention Type: OTHER

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

Interventions

individually tailored lead weight

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

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Park AG

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Principal Investigators

Stefan Hesse, MD

Role: PRINCIPAL_INVESTIGATOR

Charite - University Medicine Berlin, Medical Park Berlin

Locations

Charité University Medicine Berlin, Medical Park Berlin

Berlin, State of Berlin, Germany

Countries

Germany

References

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

Reference Type: BACKGROUND

PMID: 8443444 (View on PubMed)

Other Identifiers

NCT100111

Identifier Type: -

Identifier Source: org_study_id