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

January 10, 2011 updated by: Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13507
        • Charité University Medicine Berlin, Medical Park Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with lagophthalmos due to surgery, central or peripheral paresis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohort
cohort of consecutively enrolled patients with lagophthalmos
Other: individually tailored lead weight
patients were treated with an individually tailored lead weight to train M. orbicularis oculi during day time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
responder lid closure
responder was created, whether the lid closure was a) not possible, b) partially possible, c) completely possible

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Medical Park AG

Investigators

  • Principal Investigator: Stefan Hesse, MD, Charite - University Medicine Berlin, Medical Park Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (ESTIMATE)

January 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT100111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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