Post Enucleation Socket Syndrome Study
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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:
- allow more accurate volume estimation of the primary orbital implants prior to enucleation surgeries, thus minimize the development of PESS;
- evaluate the volumetric & structural anomalies that constitute PESS
- be used for the development of a new customized secondary orbital implant to manage superior sulcus deformity in PESS.
| Condition |
|---|
|
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 :
- standard uncomplicated enucleation,
- with primary hydroxyapatite or MEDPORE implant of size 20mm diameter or larger well placed within the posterior Tenon's space,
- and re-suturing of the four recti muscles anterior to the equator,
- Aged 21 and above
- In good general health
Exclusion Criteria:
- Other types of orbital implant or implant size smaller than 20mm
- History of any disorders or surgery of the orbits: e.g. orbital trauma, repair of orbital fracture, orbital tumors, thyroid eye disease, orbital inflammatory disease, orbital irradiation
- History of any disorders or surgery of the extraocular muscles: e.g. myopathy, strabismus surgery
- History of any disorders or surgery of the eyelids: e.g. congenital ptosis, Horner's syndrome, ptosis surgery
- Pregnancy
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
Publications:
| 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 |
Keywords provided by Singapore National Eye Centre:
|
Post enucleation socket syndrome Multi-slice computed tomography scan Prospective studies Tomography, X Ray Computed |
Additional relevant MeSH terms:
|
Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013