CI

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ClinicalIndex Comparison Record
N/ACompleted· 10 target
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00347282
NCT00347282N/ACompleted

Post-enucleation Socket Syndrome Study (PESSS): Part 1 - Three Dimensional Volumetric Assessment of Anophthalmic Sockets With the New Multi-detector Computed Tomographic Technology

Singapore National Eye Centre·observational·Posted Jul 4, 2006·Updated May 12, 2010

In Brief

An observational study for Eye Enucleation and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

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: 1. allow more accurate volume estimation of the primary orbital implants prior to enucleation surgeries, thus minimize the development of PESS; 2. evaluate the volumetric \& structural anomalies that constitute PESS 3. be used for the development of a new customized secondary orbital implant to manage superior sulcus deformity in PESS.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSingapore
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2006
Enrollment StartMar 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.0 years ago