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Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf

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ClinicalTrials.gov Identifier: NCT03712995
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario 12 de Octubre

Brief Summary:
To study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid

Condition or disease Intervention/treatment Phase
Reconstructive Surgical Procedure Procedure: 'Cutler-Beard modified with graft' Not Applicable

Detailed Description:

A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.

Functional, cosmetic outcomes and postoperative complications were evaluated.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Retrospective review of charts of the patients enrolled
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstruction of Upper Eyelid Defects Secondary to Malignant Tumors With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graft
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cutler-Beard modified with graft
Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf
Procedure: 'Cutler-Beard modified with graft'
A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.
Other Name: Modified Cutler-Beard technique with tarsoconjunctival graft




Primary Outcome Measures :
  1. Eyelid retraction [ Time Frame: 42 months ]
    Upper eyelid retraction in mm


Secondary Outcome Measures :
  1. Retraction of the donor lower eyelid [ Time Frame: 42 months ]
    Lower eyelid retraction in mm

  2. Lagophthalmos [ Time Frame: 42 months ]
    Excessive aperture of the eyelids, in mm

  3. Lid margin stability [ Time Frame: 42 months ]
    in mm

  4. Eyelid status [ Time Frame: 42 months ]
    Number of complications, being 0 the best result


Other Outcome Measures:
  1. Symptoms of the patients [ Time Frame: 42 months ]
    Number of symptoms referred by the patient, being 0 the best result



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Upper eyelid defect after tumor resection

Exclusion Criteria:

  • previous surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712995


Sponsors and Collaborators
Hospital Universitario 12 de Octubre
Investigators
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Study Chair: Enrique Mencía-Gutiérrez, MD Hospital Universitario 12 de Octubre, Madrid, Spain

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Responsible Party: Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT03712995     History of Changes
Other Study ID Numbers: RUE-2018
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Publication of the results in a journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Universitario 12 de Octubre:
Cutler-Beard
tarsoconjunctival graft
upper eyelid