Aesthetic and Functional Outcomes of Eyelid Reconstruction After Excision of Periocular Tumors

June 27, 2021 updated by: Haitham Thabit, Sohag University
  • To determine the aesthetic and functional outcomes of different techniques used in eyelid reconstruction following periocular defects.
  • To determine the complications of eyelid reconstruction and how to prevent them

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will undergo the following :

Direct eyelid closure will be done in small defects with or without canthyolysis Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps

Patients will be followed up as regard

  • The stability of flap or graft
  • The vertical and horizontal measurements of palbepral fissure
  • Detection of any complications
  • Donor site follow up
  • Patient degree of satisfaction

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with periocular tumors and candidate for excision

Exclusion Criteria:

  • patients with history of radiotherapy or chemotherapy

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Eyelid reconstruction
Direct eyelid closure will be done in small defects after periocular defects with or without canthyolysis , Larger defects will be reconstructed with anterior and posterior lamella reconstruction using grafts and flaps
Other: Eyelid reconstruction
Assessment of differrent techniques in anterior and posterior lamella reconstruction after periocular defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability of graft or flap
Time Frame: 9 months
Assessment of flap or graft as regard the function , stability and colour match
9 months
Measurement of vertical and horizontal diameters of the palbepral fissure
Time Frame: 9 months
Measurement of the length between the inner and outer canthus by ruler to determine the horizontal diameter of the palbepral fissure , and measurement of the distance between upper and lower lid margins at the pupil center to determine the vertical palbepral fissure diameter
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Donor site
Time Frame: 9 months
Follow up of donor site
9 months
complications
Time Frame: 9 months
Follow up of complications
9 months

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Study Director: Ali Ismail, Professor, Professor

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 (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 27, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

June 27, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-05-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The Functional and cosmetic outcomes of differrent methods of eye lid reconstruction

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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