NCT01207713

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
Last Updated

September 23, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

September 22, 2010

Last Update Submit

September 22, 2010

Conditions

Eligibility Criteria

Age3 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Officials

  • Juan Ye, MD,Ph.D

    second affiliated hospital,zhejiang university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

September 23, 2010

Record last verified: 2010-09