A Modified Orbital Implantation Technique in Enucleation

Completed

• Conditions: Orbital Implants

• Registration Number: NCT01207713
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

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 Timeline

• Study Start: 2009-04
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2010-09
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Last Update Submitted: 2010-09-22
• Study First Posted: 2010-09-23
• Last Update Posted: 2010-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified