Incomplete Closure of Lid Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 152 |
| Est. completion date | August 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité University Medicine Berlin, Medical Park Berlin | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany | Medical Park AG |
Germany,
Müller-Jensen K, Müller-Jensen G. [Surgical and conservative treatment of lagophthalmus (facial paralysis). II]. Ophthalmologe. 1993 Feb;90(1):27-30. German. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | responder lid closure | responder was created, whether the lid closure was a) not possible, b) partially possible, c) completely possible | No | |
| Secondary | skin irritation | was there a skin irritation after applicating the lead weight; yes or no | Yes |