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

NCT04662190 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-01-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Societat Catalana d'Oftalmologia

    collaborator UNKNOWN

  • Althaia Xarxa Assistencial Universitària de Manresa

    lead OTHER

Principal Investigators

  • Eduard Pedemonte-Sarrias, Md, PhD · Althaia Xarxa Assistencial Universitària de Manresa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662190 on ClinicalTrials.gov