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

Surgery Clinical Trial

Official title:

Deep Lateral Wall Partial Rim-Sparing Orbital Decompression With Ultrasonic Bone Removal for Treatment of Thyroid-Related Orbitopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025034
• Other study ID #: DLWP-R2019
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 1, 2019

Study information

• Verified date: July 2019
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 1, 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria: Exopthalmos -

Exclusion Criteria: Previous procedures

-

Related Conditions & MeSH terms

• Exophthalmos
• Graves Ophthalmopathy
• Orbitopathy, Graves
• Surgery

Intervention

Procedure:
• Orbital decompression with ultrasonic bone removal
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre	Hospital del Río Hortega, The Queen Elizabeth Hospital

References & Publications (4)

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 — View 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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in proptosis	Measured by the difference in Hertel exophthalmometry	33 months
Secondary	Visual acuity	Using Snellen scale, decimal fraction	33 months
Secondary	Lagophthalmos	Presence of lagophthalmos	33 months
Secondary	Eyelid retraction	Measured by upper eyelid margin distance to the corneal reflex and lower eyelid margin distance to the corneal reflex	33 months
Secondary	Keratopathy	Presence of exposure keratopathy	33 months

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