NCT03712995

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
Last Updated

December 10, 2018

Status Verified

October 1, 2018

Enrollment Period

6 years

First QC Date

October 10, 2018

Last Update Submit

December 7, 2018

Conditions

Reconstructive Surgical Procedure

Keywords

Cutler-Beardtarsoconjunctival graftupper eyelid

Outcome Measures

Primary Outcomes (1)

  • Eyelid retraction

    Upper eyelid retraction in mm

    42 months

Secondary Outcomes (4)

  • Retraction of the donor lower eyelid

    42 months

  • Lagophthalmos

    42 months

  • Lid margin stability

    42 months

  • Eyelid status

    42 months

Other Outcomes (1)

  • Symptoms of the patients

    42 months

Study Arms (1)

Cutler-Beard modified with graft

EXPERIMENTAL

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

Procedure: 'Cutler-Beard modified with graft'

Interventions

'Cutler-Beard modified with graft'PROCEDURE

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.

Also known as: Modified Cutler-Beard technique with tarsoconjunctival graft
Cutler-Beard modified with graft

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Upper eyelid defect after tumor resection

You may not qualify if:

  • previous surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Enrique Mencía-Gutiérrez, MD

    Hospital Universitario 12 de Octubre, Madrid, Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Retrospective review of charts of the patients enrolled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 19, 2018

Study Start

January 1, 2011

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

December 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Publication of the results in a journal