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
About this trial
This is an interventional treatment trial for Exophthalmos focused on measuring Decompression, Thyroid-related, Orbitopathy
Eligibility Criteria
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
NCT ID
NCT04025034
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
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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