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NCT04662190 Clinical Trial

Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.

Surgical Procedure, Unspecified Clinical Trial

Official title:
Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04662190
Other study ID # CEI 20-16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 5, 2021
Est. completion date June 2025

Study information
Verified date February 2024
Source Althaia Xarxa Assistencial Universitària de Manresa
Contact Eduard Pedemonte-Sarrias, MD, PhD
Phone +34678091233
Email epedemonte@althaia.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicentric, randomized, single-blinded clinical trial to evaluate the efficacy and safety of 3D printing for the planification and simulation of orbital decompression surgery for thyroid-associated orbitopathy.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of inactive thyroid-associated orbitopathy requiring bilateral orbital decompression (moderate-severe in EUGOGO classification). - Volunteers older than 18 years old. - Ability to read. - Acceptation to participate and signature of informed consent. Exclusion Criteria: - Younger than 18 years old. - Previous orbital surgery. - Any coexisting disease preventing follow-up.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 3D printing model/guide.
Orbital decompression surgery will be previously planned and simulated using 3D-printed individualized models. In the operating room, surgery will be assisted with 3D-printed individualized guides.
Procedure:
• Standard surgery
Orbital decompression surgery will be previously planned and simulated using the actual standard methods.

Locations
Country Name City State
Spain Eduard Pedemonte Sarrias Manresa Barcelona

Sponsors (2)
Lead Sponsor Collaborator
Althaia Xarxa Assistencial Universitària de Manresa Societat Catalana d'Oftalmologia

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative complications Intraoperative complications 6 months
Primary Postoperative complications Postoperative complications 6 months
Primary Exophthalmos Exophthalmos measured in millimeters 6 months
Primary Diplopia Diplopia correction 6 months
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