A Modified Orbital Implantation Technique in Enucleation
September 22, 2010 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Evaluation of the Functional and Cosmetic Outcome of Enucleation With Rectus End-to-end Suturing Surgical Technique in Coralline Hydroxyapatite Orbital Implants
To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique in hydroxyapatite orbital implants
Study Overview
Status
Completed
Conditions
Detailed Description
To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique between 2005 and 2009.
All the patients underwent primary enucleation and implantation of non-wrapped HA implants using a technique that involves drawing the ends of the rectus muscles anteriorly and suturing them into a cross-shape in front of the implant.
Main outcome measures included occurrence of pain or discharge, soft tissue problems, implant motility, upper lid position, and patients' satisfaction.
Study Type
Observational
Enrollment (Actual)
45
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
3 years to 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients who had received hydroxyapatite orbital implants after primary enucleation by a single surgeon from July 2005 to March 2009
Description
Inclusion Criteria:
-
Exclusion Criteria:
bilateral enucleation severely traumatized orbits, and little or no function of the extraocular muscles adjunctive radiotherapy and/or chemotherapy diabetes vessel inflammation follow-up of less than 6 months
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juan Ye, MD,Ph.D, second affiliated hospital,zhejiang university
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
April 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 22, 2010
First Submitted That Met QC Criteria
September 22, 2010
First Posted (Estimate)
September 23, 2010
Study Record Updates
Last Update Posted (Estimate)
September 23, 2010
Last Update Submitted That Met QC Criteria
September 22, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- SAHZhejiangU
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