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Completed

NCT Number: NCT04025034

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Exopthalmos -

Exclusion criteria

Previous procedures

-

Treatment and study plan

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.

Primary outcomes

  1. Orbital decompression in exophthalmos in treatment of thyroid-related orbitopahty

    Time frame: 33 months

    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.

  2. Change in proptosis

    Time frame: 33 months

    Measured by the difference in Hertel exophthalmometry

Secondary outcomes

  1. Visual acuity

    Time frame: 33 months

    Using Snellen scale, decimal fraction

  2. Lagophthalmos

    Time frame: 33 months

    Presence of lagophthalmos

  3. Eyelid retraction

    Time frame: 33 months

    Measured by upper eyelid margin distance to the corneal reflex and lower eyelid margin distance to the corneal reflex

  4. Keratopathy

    Time frame: 33 months

    Presence of exposure keratopathy

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Collaborators

  • Hospital del Rio Hortega
  • The Queen Elizabeth Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Jul 18, 2019
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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