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OpenTrials
Completed

NCT Number: NCT01274689

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité University Medicine Berlin, Medical Park Berlin

Berlin, State of Berlin, 13507, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

individually tailored lead weight

Other

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

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

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Medical Park AG

Registry information

Important dates

Study start
1997
Primary completion
2010
Study completion
2010
First posted
Jan 11, 2011
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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