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Recruiting NCT04662190

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

Trial Parameters

Condition Thyroid Associated Ophthalmopathy
Sponsor Althaia Xarxa Assistencial Universitària de Manresa
Study Type INTERVENTIONAL
Phase N/A
Enrollment 12
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-07-05
Completion 2025-12
Interventions
3D printing model/guide.Standard surgery

Brief 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 Criteria

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.

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