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Post Enucleation Socket Syndrome Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347282
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 12, 2010
Information provided by:
Singapore National Eye Centre

Brief 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.

Condition or disease
Eye Enucleation Orbit Surgery Postoperative Complications

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 10 participants
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
Study Start Date : March 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347282

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Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
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Principal Investigator: Sunny Shen, MBBS, MMed(Ophth), MRCS(Ed) Singapore National Eye Centre


Layout table for additonal information Identifier: NCT00347282     History of Changes
Other Study ID Numbers: R440/35/2005
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: May 2010

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:
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Postoperative Complications
Pathologic Processes