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| Sponsor: | Singapore National Eye Centre |
|---|---|
| Information provided by: | Singapore National Eye Centre |
| ClinicalTrials.gov Identifier: | NCT00347282 |
Purpose
Superior sulcus deformity in post-enucleation socket syndrome (PESS) may pose a significant cosmetic blemish after enucleation surgery despite apparently adequate orbital volume replacement. The underlying reasons include the lack of accurate pre-operative volumetric assessment of the anophthalmic socket, leading to either under or over estimation of the orbital implant required and the shifting in orbital and periocular structures that may occur post enucleation. Conventional imaging studies (computed tomography and magnetic resonance imaging) have been used to study the anatomy of anophthalmic sockets, but there are several drawbacks such as poor image quality for detailed volumetric assessment, long exposure time with possible motion artifact and etc. The new multi-detector computed tomographic technology is the latest advance in diagnostic radiology that allows rapid high resolution images to be obtained for three dimensional reconstruction and volumetric assessment. This new imaging modality will contribute greatly to the understanding of PESS and the surgical planning of anophthalmic sockets reconstruction.
This is a pilot study aiming to collect clinical data on the volumetric and structural changes in PESS. The information obtained will:
| Condition |
|---|
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Eye Enucleation Orbit Surgery Postoperative Complications |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Post-enucleation Socket Syndrome Study (PESSS): Part 1 - Three Dimensional Volumetric Assessment of Anophthalmic Sockets With the New Multi-detector Computed Tomographic Technology |
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2006 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients who had enucleation surgery with primary orbital implant
Inclusion Criteria:
Patient who underwent :
Exclusion Criteria:
Contacts and Locations| Singapore | |
| Singapore Eye Research Institute | |
| Singapore, Singapore, 168751 | |
| Principal Investigator: | Sunny Shen, MBBS, MMed(Ophth), MRCS(Ed) | Singapore National Eye Centre |
More Information
| ClinicalTrials.gov Identifier: | NCT00347282 History of Changes |
| Other Study ID Numbers: | R440/35/2005 |
| Study First Received: | June 29, 2006 |
| Last Updated: | May 11, 2010 |
| Health Authority: | Singapore: Health Sciences Authority |
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Post enucleation socket syndrome Multi-slice computed tomography scan Prospective studies Tomography, X Ray Computed |
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Postoperative Complications Pathologic Processes |