Post Enucleation Socket Syndrome Study

This study has been completed.
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00347282
First received: June 29, 2006
Last updated: May 11, 2010
Last verified: May 2010
  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:

  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
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

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

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
Study Population

Patients who had enucleation surgery with primary orbital implant

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00347282

Locations
Singapore
Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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 July 24, 2014