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

Reconstruction of Upper Eyelid Defects Secondary to Malignant Tumors With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graft

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

Study Overview

• Status: Completed
• Conditions: Reconstructive Surgical Procedure
• Intervention / Treatment: Procedure: 'Cutler-Beard modified with graft'

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Upper eyelid defect after tumor resection

Exclusion Criteria:

• previous surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Modified Cutler-Beard technique with tarsoconjunctival graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eyelid retraction	Upper eyelid retraction in mm	42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retraction of the donor lower eyelid	Lower eyelid retraction in mm	42 months
Lagophthalmos	Excessive aperture of the eyelids, in mm	42 months
Lid margin stability	in mm	42 months
Eyelid status	Number of complications, being 0 the best result	42 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of the patients	Number of symptoms referred by the patient, being 0 the best result	42 months

Collaborators and Investigators

• Sponsor: Hospital Universitario 12 de Octubre
• Investigators: Study Chair: Enrique Mencía-Gutiérrez, MD, Hospital Universitario 12 de Octubre, Madrid, Spain

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Cutler-Beard; tarsoconjunctival graft; upper eyelid
• Other Study ID Numbers: RUE-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Publication of the results in a journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No