Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-07 @ 9:29 PM
Study NCT ID:
NCT04025034
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Lateral Wall Partial Rim-Sparing Orbital Decompression for Treatment of Thyroid-Related Orbitopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Retrsopective, non-comparative case series'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orbital decompression in exophthalmos in treatment of thyroid-related orbitopahty', 'timeFrame': '33 months', '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.'}, {'measure': 'Change in proptosis', 'timeFrame': '33 months', 'description': 'Measured by the difference in Hertel exophthalmometry'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '33 months', 'description': 'Using Snellen scale, decimal fraction'}, {'measure': 'Lagophthalmos', 'timeFrame': '33 months', 'description': 'Presence of lagophthalmos'}, {'measure': 'Eyelid retraction', 'timeFrame': '33 months', 'description': 'Measured by upper eyelid margin distance to the corneal reflex and lower eyelid margin distance to the corneal reflex'}, {'measure': 'Keratopathy', 'timeFrame': '33 months', 'description': 'Presence of exposure keratopathy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decompression', 'Thyroid-related', 'Orbitopathy'], 'conditions': ['Exophthalmos', 'Orbitopathy, Graves', 'Surgery']}, 'referencesModule': {'availIpds': [{'url': 'http://microsoftwindows.com', 'type': 'Informed Consent Form', 'comment': 'Navigator'}], 'references': [{'pmid': '16140250', 'type': 'RESULT', '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.'}, {'pmid': '10873993', 'type': 'RESULT', '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."}, {'pmid': '16286624', 'type': 'RESULT', '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.'}, {'pmid': '20305505', 'type': 'RESULT', '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.'}, {'pmid': '31885895', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://microsoftwindows.com', 'label': 'Navigator'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSONOPET® 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.\n\nThe 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).\n\nSurgical 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Exopthalmos -\n\nExclusion Criteria: Previous procedures\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04025034', 'briefTitle': 'Deep Lateral Wall Partial Rim-Sparing Orbital Decompression for Treatment of Thyroid-Related Orbitopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Deep Lateral Wall Partial Rim-Sparing Orbital Decompression With Ultrasonic Bone Removal for Treatment of Thyroid-Related Orbitopathy', 'orgStudyIdInfo': {'id': 'DLWP-R2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Use of SONOPET(R) to orbital surgery.', 'interventionNames': ['Procedure: Orbital decompression with ultrasonic bone removal']}], 'interventions': [{'name': 'Orbital decompression with ultrasonic bone removal', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maria Ugalde-Diez, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': '12 de Octubre Hospital, Madrid'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '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)', 'ipdSharing': 'YES', '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)', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital del Rio Hortega', 'class': 'OTHER'}, {'name': 'The Queen Elizabeth Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Enrique Mencia-Gutierrez', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}