A Modified Orbital Implantation Technique in Enucleation

NCT ID: NCT01207713

Last Updated: 2010-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Orbital Implants

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Principal Investigators

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Juan Ye, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

second affiliated hospital,zhejiang university

Other Identifiers

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SAHZhejiangU

Identifier Type: -

Identifier Source: org_study_id