Deep Lateral Wall Partial Rim-Sparing Orbital Decompression for Treatment of Thyroid-Related Orbitopathy

NCT04025034 | Completed DMC

• 1 other identifier: DLWP-R2019
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The described technique of DLW-PRS decompression for TRO using SONOPET(R) appears to be safe and effective, reducing the complications associated with decompressing the orbital floor and medial wall. The mechanical characteristics of this surgical too provide protection to adjacent dura mater and neurovascular structures when working in narrow spaces.

Conditions

Exophthalmos; Orbitopathy, Graves; Surgery

Keywords

Decompression; Thyroid-related; Orbitopathy

Outcome Measures

Primary Outcomes (2)

• Orbital decompression in exophthalmos in treatment of thyroid-related orbitopahty

  Decompression with a bone-cutting ultrasonic aspirator that can be customized for variable decompression of the orbit by tailoring the amount of bone removed from each wall.

  33 months

• Change in proptosis

  Measured by the difference in Hertel exophthalmometry

  33 months

Secondary Outcomes (4)

• Visual acuity

  33 months

• Lagophthalmos

  33 months

• Eyelid retraction

  33 months

• Keratopathy

  33 months

Study Arms (1)

Study Group

EXPERIMENTAL

Use of SONOPET(R) to orbital surgery.

Procedure: Orbital decompression with ultrasonic bone removal

Interventions

Orbital decompression with ultrasonic bone removal PROCEDURE

Deep lateral wall partial rim-sparing decompression for thyroid-related orbitopathy using SONOPET® appears to be safe and effective, reducing the complications associated and damage to neurovascular structures.

Study Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Hospital del Rio Hortega: collaborator
• The Queen Elizabeth Hospital: collaborator

Related Publications (5)

• Baldeschi L, MacAndie K, Hintschich C, Wakelkamp IM, Prummel MF, Wiersinga WM. The removal of the deep lateral wall in orbital decompression: its contribution to exophthalmos reduction and influence on consecutive diplopia. Am J Ophthalmol. 2005 Oct;140(4):642-7. doi: 10.1016/j.ajo.2005.04.023. Epub 2005 Sep 2.

  PMID: 16140250 RESULT

• Paridaens DA, Verhoeff K, Bouwens D, van Den Bosch WA. Transconjunctival orbital decompression in Graves' ophthalmopathy: lateral wall approach ab interno. Br J Ophthalmol. 2000 Jul;84(7):775-81. doi: 10.1136/bjo.84.7.775.

  PMID: 10873993 RESULT

• Sivak-Callcott JA, Linberg JV, Patel S. Ultrasonic bone removal with the Sonopet Omni: a new instrument for orbital and lacrimal surgery. Arch Ophthalmol. 2005 Nov;123(11):1595-7. doi: 10.1001/archopht.123.11.1595.

  PMID: 16286624 RESULT

• Cho RI, Choe CH, Elner VM. Ultrasonic bone removal versus high-speed burring for lateral orbital decompression: comparison of surgical outcomes for the treatment of thyroid eye disease. Ophthalmic Plast Reconstr Surg. 2010 Mar-Apr;26(2):83-7. doi: 10.1097/IOP.0b013e3181b8e614.

  PMID: 20305505 RESULT

• Bengoa-Gonzalez A, Galindo-Ferreiro A, Mencia-Gutierrez E, Sanchez-Tocino H, Martin-Clavijo A, Lago-Llinas MD. Deep Lateral Wall Partial Rim-Sparing Orbital Decompression with Ultrasonic Bone Removal for Treatment of Thyroid-Related Orbitopathy. J Ophthalmol. 2019 Dec 2;2019:9478512. doi: 10.1155/2019/9478512. eCollection 2019.

  PMID: 31885895 DERIVED

Related Links

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MeSH Terms

Conditions

Exophthalmos; Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Orbital Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria Ugalde-Diez, M.D., Ph.D.

  12 de Octubre Hospital, Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Retrsopective, non-comparative case series

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 18, 2019
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: A review was carried out, from January 2015 to September 2017, of all patients treated with ultrasound DLW-PRS decompression using a SONOPET® (Striker, Kalamazoo, MI, USA)
• Access Criteria: The primary outcome was the change in proptosis (measured by the difference in Hertel exophthalmometry measurements). Other secondary outcomes were changes in visual acuity (VA) (using Snellen scale, decimal fraction), presence of lagophthalmos, eyelid retraction (measured by superior eyelid margin distance to the corneal reflex (MRD1) and inferior eyelid margin distance to the corneal reflex (MRD2)), and presence of exposure-related symptoms and exposure keratopathy.