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

Primary Purpose

Exophthalmos, Orbitopathy, Graves, Surgery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orbital decompression with ultrasonic bone removal
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exophthalmos focused on measuring Decompression, Thyroid-related, Orbitopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Exopthalmos -

Exclusion Criteria: Previous procedures

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study Group

    Arm Description

    Use of SONOPET(R) to orbital surgery.

    Outcomes

    Primary Outcome Measures

    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.
    Change in proptosis
    Measured by the difference in Hertel exophthalmometry

    Secondary Outcome Measures

    Visual acuity
    Using Snellen scale, decimal fraction
    Lagophthalmos
    Presence of lagophthalmos
    Eyelid retraction
    Measured by upper eyelid margin distance to the corneal reflex and lower eyelid margin distance to the corneal reflex
    Keratopathy
    Presence of exposure keratopathy

    Full Information

    First Posted
    July 15, 2019
    Last Updated
    July 18, 2019
    Sponsor
    Hospital Universitario 12 de Octubre
    Collaborators
    Hospital del Río Hortega, The Queen Elizabeth Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04025034
    Brief Title
    Deep Lateral Wall Partial Rim-Sparing Orbital Decompression for Treatment of Thyroid-Related Orbitopathy
    Official Title
    Deep Lateral Wall Partial Rim-Sparing Orbital Decompression With Ultrasonic Bone Removal for Treatment of Thyroid-Related Orbitopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    January 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario 12 de Octubre
    Collaborators
    Hospital del Río Hortega, The Queen Elizabeth Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    We included in this review patients who had exophthalmos at presentation (using Hertel's exophthalmometer), underwent surgery for rehabilitation of disfiguring exophthalmos and had controlled thyroid function. All patients had a minimum follow up of 6 months. Procedures that potentially might have altered the amount of retroplacement achieved by lateral wall removal, such as fat excision, rim advancement, or decompression into the paranasal sinuses, were not performed. Patients with any history of previous procedures that potentially might have altered exophthalmos measurements were also excluded for the purposes of this study. SONOPET® Ultrasonic Aspirator. The SONOPET® ultrasonic aspirator, consists of an ultrasonic handpiece that is connected to a base control module. The unit is foot-pedal controlled. The base module houses the controls to regulate the irrigation rate (between 3 and 40 mL/min), aspiration and ultrasound power parameters of the machine. The power setting is expressed as a percentage of that maximum. Aspiration reaches 500 mmHg and the aspiration setting on the machine is also expressed as a percentage of that maximum. The irrigation rate is expressed in milliliters per minute.18 Aspiration occurs through an opening at the distal aspect of the handpiece tip and the irrigation fluid (normal saline at 20°C) flows through a white irrigation sleeve surrounding the handpiece tip. The handpiece oscillates in a nonrotational fashion up to 25,000 times per second with a 0.36 mm width variation. The SONOPET®'s primary mechanism of action is torsional oscillation of a metal bone rasp at 25 kHz. This frequency is ideal for bone removal,22 as the microenvironment created only cuts mineralized tissue, while soft tissues are best cut at frequencies ≥34 kHz.23 The universal handpiece fits multiple interchangeable tips that have varying lengths, sizes, and shapes designed for specific soft tissue or bone removal purposes.22 Different sizes and angles for the cutting surface are also available. The tip used in this series is a serrated aggressive knife and the superlong payner 360°shape designed for bone fragmentation and removal24 (Figures 1 D, 2 A). Surgical technique. The procedure was performed with the patient in a supine position under general anesthesia. A single dose of IV dexamethasone (8 mg) and a 1 gr IV cefazoline were given during surgery. After corneal lubrication, the patient was prepped and draped in sterile fashion. The marked triangle incision was incised (Figure 1, A) and an initial lateral canthotomy was made in a "crow's foot" using a no. 15 Bard-Parker® surgical blade (Becton Dickinson, Hancock, NY, USA) . Dissection was performed in the preseptal plane to provide wide exposure of the rim of the lateral orbital wall(Figure 1, B). The periosteum was incised using a needle-tip monopolar electrocautery and the lateral wall was completely exposed by cutting cautery and periosteal elevators (Figure 1, C). The posterior leaf of the periosteum was mobilized and reflected, along with the temporalis muscle; this minimizes damage to the temporalis muscle during surgery and reduces future temporal hollowing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exophthalmos, Orbitopathy, Graves, Surgery
    Keywords
    Decompression, Thyroid-related, Orbitopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Retrsopective, non-comparative case series
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    Use of SONOPET(R) to orbital surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Orbital decompression with ultrasonic bone removal
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Orbital decompression in exophthalmos in treatment of thyroid-related orbitopahty
    Description
    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.
    Time Frame
    33 months
    Title
    Change in proptosis
    Description
    Measured by the difference in Hertel exophthalmometry
    Time Frame
    33 months
    Secondary Outcome Measure Information:
    Title
    Visual acuity
    Description
    Using Snellen scale, decimal fraction
    Time Frame
    33 months
    Title
    Lagophthalmos
    Description
    Presence of lagophthalmos
    Time Frame
    33 months
    Title
    Eyelid retraction
    Description
    Measured by upper eyelid margin distance to the corneal reflex and lower eyelid margin distance to the corneal reflex
    Time Frame
    33 months
    Title
    Keratopathy
    Description
    Presence of exposure keratopathy
    Time Frame
    33 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Exopthalmos - Exclusion Criteria: Previous procedures -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Ugalde-Diez, M.D., Ph.D.
    Organizational Affiliation
    12 de Octubre Hospital, Madrid
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    To describe the results of thyroid-related orbitopathy (TRO) treated by ultrasound lateral deep lateral wall bony decompression with partial rim sparing (DLW-PRS)
    IPD Sharing 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)
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    16140250
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    10873993
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    16286624
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    20305505
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    31885895
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://microsoftwindows.com
    Description
    Navigator
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Informed Consent Form
    Available IPD/Information URL
    http://microsoftwindows.com
    Available IPD/Information Comments
    Navigator

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

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