A Modified Orbital Implantation Technique in Enucleation

This study has been completed.
Sponsor:
Information provided by:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01207713
First received: September 22, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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


Condition Phase
Orbital Implants
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:

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


Enrollment: 45
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Years to 73 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jianan Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT01207713     History of Changes
Other Study ID Numbers: SAHZhejiangU
Study First Received: September 22, 2010
Last Updated: September 22, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014