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

Althaia Xarxa Assistencial Universitària de Manresa12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Thyroid Associated Ophthalmopathy Surgical Procedure, Unspecified

Interventions

3D printing model/guide.DEVICE

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.

Standard surgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eduard Pedemonte Sarrias

Manresa, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Intraoperative complications

Time frame: 6 months

Postoperative complications

Time frame: 6 months

Exophthalmos

Exophthalmos measured in millimeters

Time frame: 6 months

Diplopia

Diplopia correction

Time frame: 6 months

Central Contacts

Eduard Pedemonte-Sarrias, MD, PhD

CONTACT

+34678091233 epedemonte@althaia.cat

Anna Arnau, PhD

CONTACT

aarnau@althaia.cat

Data from ClinicalTrials.gov

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