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

Completed

• Conditions: Incomplete Closure of Lid; Parotis Tumor; m. Orbicularis Oculi Paresis
• Interventions: Other: individually tailored lead weight

• Registration Number: NCT01274689
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-05
• Status Verified: 2008-06
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Last Update Submitted: 2011-01-10
• Study First Posted: 2011-01-11
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cohort	individually tailored lead weight	cohort of consecutively enrolled patients with lagophthalmos

Primary Outcome Measures

Name	Time	Method
responder lid closure		responder was created, whether the lid closure was a) not possible, b) partially possible, c) completely possible

Secondary Outcome Measures

Name	Time	Method
skin irritation		was there a skin irritation after applicating the lead weight; yes or no

Trial Locations

Locations (1)

Charité University Medicine Berlin, Medical Park Berlin; 🇩🇪 Berlin, Germany