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Post Enucleation Socket Syndrome Study

NCT00347282 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2010-05-12

No results posted yet for this study

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.

Conditions

  • Eye Enucleation
  • Orbit Surgery
  • Postoperative Complications

Sponsors & Collaborators

  • Singapore National Eye Centre

    lead OTHER_GOV

Principal Investigators

  • Sunny Shen, MBBS, MMed(Ophth), MRCS(Ed) · Singapore National Eye Centre

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00347282 on ClinicalTrials.gov