RecruitingNot ApplicableNCT04662190

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

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


Sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Enrollment

12 participants

Start Date

Jul 5, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • Younger than 18 years old.
  • Previous orbital surgery.
  • Any coexisting disease preventing follow-up.

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Interventions

DEVICE3D 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.

PROCEDUREStandard surgery

Orbital decompression surgery will be previously planned and simulated using the actual standard methods.


Locations(1)

Eduard Pedemonte Sarrias

Manresa, Barcelona, Spain

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NCT04662190


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