NCT04662190

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Associated Ophthalmopathy
• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-05
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2020-12-10
• Last updated: 2025-01-31

Locations

1 site across 1 country: Spain