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

January 30, 2025 updated by: Eduard Pedemonte-Sarrias, Althaia Xarxa Assistencial Universitària de Manresa

Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Manresa, Barcelona, Spain, 08243
        • Recruiting
        • Eduard Pedemonte Sarrias
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control grup
Conventional surgery.
Procedure: Standard surgery
Orbital decompression surgery will be previously planned and simulated using the actual standard methods.
Experimental: Intervention group
Surgery planned, simulated and guided by 3D printing.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: 6 months
Intraoperative complications
6 months
Postoperative complications
Time Frame: 6 months
Postoperative complications
6 months
Exophthalmos
Time Frame: 6 months
Exophthalmos measured in millimeters
6 months
Diplopia
Time Frame: 6 months
Diplopia correction
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Collaborators

Societat Catalana d'Oftalmologia

Investigators

  • Principal Investigator: Eduard Pedemonte-Sarrias, Md, PhD, Althaia Xarxa Assistencial Universitària de Manresa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI 20-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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