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Post Enucleation Socket Syndrome Study
This study is not yet open for participant recruitment.
Verified by Singapore National Eye Centre, November 2005
Sponsored by: Singapore National Eye Centre
Information provided by: Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00347282
  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

MedlinePlus related topics: CT Scans
Drug Information available for: X-Rays
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
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

Further study details as provided by Singapore National Eye Centre:

Estimated Enrollment: 10
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347282

Contacts
Contact: Sunny Shen, MBBS, MMed(Ophth), MRCS(Ed) (65)81218534 sunny.she.yu@singhealth.com.sg
Contact: Karen Chee (65)63224500 karen.chee.s.l@seri.com.sg

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:
Tyers AG, Collin JR. Orbital implants and post enucleation socket syndrome. Trans Ophthalmol Soc U K. 1982 Apr;102 (Pt 1):90-2. No abstract available.
Smerdon DL, Sutton GA. Analysis of the factors involved in cosmetic failure following excision of the eye. Br J Ophthalmol. 1988 Oct;72(10):768-73.
Bartlett RE. Plastic surgery for the enucleation patient. Am J Ophthalmol. 1966 Jan;61(1):68-78. No abstract available.
Su GW, Yen MT. Current trends in managing the anophthalmic socket after primary enucleation and evisceration. Ophthal Plast Reconstr Surg. 2004 Jul;20(4):274-80.
Bilyk JR. Enucleation, evisceration, and sympathetic ophthalmia. Curr Opin Ophthalmol. 2000 Oct;11(5):372-86. Review.
Kaltreider SA, Jacobs JL, Hughes MO. Predicting the ideal implant size before enucleation. Ophthal Plast Reconstr Surg. 1999 Jan;15(1):37-43.
Custer PL, Trinkaus KM. Volumetric determination of enucleation implant size. Am J Ophthalmol. 1999 Oct;128(4):489-94.
Smith B, Obear M, Leone CR Jr. The correction of enophthalmos associated with anophthalmos by glass bead implantation. Am J Ophthalmol. 1967 Dec;64(6):1088-93. No abstract available.
Soll DB. Correction of the superior lid sulcus with subperiosteal implants. Arch Ophthalmol. 1971 Feb;85(2):188-90. No abstract available.
Iverson RE, Vistnes LM, Siegel RJ. Correction of enophthalmos in the anophthalmic orbit. Plast Reconstr Surg. 1973 May;51(5):545-54. No abstract available.
Hill JC, Radford CJ. Treatment of advancing enophthalmos in the ocular prosthetic patient: A preliminary report including a warning. Am J Ophthalmol. 1965 Sep;60(3):487-92. No abstract available.
Hneleski IS Jr, Shannon GM. Orbital floor implant. Am J Ophthalmol. 1973 Oct;76(4):540-2. No abstract available.
Spivey BE, Allen L, Stewart WB. Surgical correction of superior sulcus deformity occurring after enucleation. Am J Ophthalmol. 1976 Sep;82(3):365-70.
Riebel O. Plastic surgery on the upper eye-lid after enucleation of the eye. Br J Ophthalmol. 1976 Oct;60(10):726-7. No abstract available.
Smith B, Lisman RD. Use of sclera and liquid collagen in the camouflage of superior sulcus deformities. Ophthalmology. 1983 Mar;90(3):230-5.
Leone CR Jr. Correction of superior sulcus defects after enucleation. Adv Ophthalmic Plast Reconstr Surg. 1990;8:209-13. Review.
Soll DB. The anophthalmic socket. Ophthalmology. 1982 May;89(5):407-23.
Nugent RA, Belkin RI, Neigel JM, Rootman J, Robertson WD, Spinelli J, Graeb DA. Graves orbitopathy: correlation of CT and clinical findings. Radiology. 1990 Dec;177(3):675-82.
Smit TJ, Koornneef L, Zonneveld FW, Groet E, Otto AJ. Computed tomography in the assessment of the postenucleation socket syndrome. Ophthalmology. 1990 Oct;97(10):1347-51.
Detorakis ET, Engstrom RE, Straatsma BR, Demer JL. Functional anatomy of the anophthalmic socket: insights from magnetic resonance imaging. Invest Ophthalmol Vis Sci. 2003 Oct;44(10):4307-13.
De Potter P. Advances in imaging in oculoplastics. Curr Opin Ophthalmol. 2001 Oct;12(5):342-6. Review.
Zammit-Maempel I, Chadwick CL, Willis SP. Radiation dose to the lens of eye and thyroid gland in paranasal sinus multislice CT. Br J Radiol. 2003 Jun;76(906):418-20.

Study ID Numbers: R440/35/2005
Study First Received: June 29, 2006
Last Updated: June 30, 2006
ClinicalTrials.gov Identifier: NCT00347282  
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

Study placed in the following topic categories:
Postoperative Complications

Additional relevant MeSH terms:
Disease
Pathologic Processes
Syndrome

ClinicalTrials.gov processed this record on February 05, 2009