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A Modified Orbital Implantation Technique in Enucleation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01207713
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : September 23, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique in hydroxyapatite orbital implants

Condition or disease Phase
Orbital Implants Phase 4

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 Design

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of the Functional and Cosmetic Outcome of Enucleation With Rectus End-to-end Suturing Surgical Technique in Coralline Hydroxyapatite Orbital Implants
Study Start Date : April 2009
Primary Completion Date : October 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   None Retained
The investigators reviewed surgical records from July 2005 to March 2009, to identify patients who had received hydroxyapatite orbital implants after primary enucleation by a single surgeon

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 73 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Contacts and Locations

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): NCT01207713


Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Principal Investigator: Juan Ye, MD,Ph.D second affiliated hospital,zhejiang university
More Information

Responsible Party: Jianan Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT01207713     History of Changes
Other Study ID Numbers: SAHZhejiangU
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010