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

Althaia Xarxa Assistencial Universitària de Manresa

Status: Enrolling

Conditions: Thyroid Associated Ophthalmopathy; Surgical Procedure, Unspecified

Treatments: Procedure: Standard surgery; Device: 3D printing model/guide.

Study type: Interventional

Funder types: Other

Identifiers

NCT04662190

CEI 20-16

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Control grup

Active Comparator group

Description:

Conventional surgery.

Treatment:

Procedure: Standard surgery

Intervention group

Experimental group

Description:

Surgery planned, simulated and guided by 3D printing.

Treatment:

Device: 3D printing model/guide.