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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-05

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Thyroid Associated Ophthalmopathy Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control grup

Conventional surgery.

Group Type ACTIVE_COMPARATOR

Standard surgery

Intervention Type PROCEDURE

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

Intervention group

Surgery planned, simulated and guided by 3D printing.

Group Type EXPERIMENTAL

3D printing model/guide.

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Standard surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.