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Completed

NCT Number: NCT04662190

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

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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Key information

Conditions

Thyroid Associated Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Surgical Procedure, Unspecified Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eduard Pedemonte Sarrias

Manresa, Barcelona, 08243, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D printing model/guide.

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.

Standard surgery

Procedure

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

Primary outcomes

  1. Intraoperative complications

    Time frame: 6 months

    Intraoperative complications

  2. Postoperative complications

    Time frame: 6 months

    Postoperative complications

  3. Exophthalmos

    Time frame: 6 months

    Exophthalmos measured in millimeters

  4. Diplopia

    Time frame: 6 months

    Diplopia correction

Sponsors and collaborators

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa

Other

Collaborators

  • Societat Catalana d'Oftalmologia

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2020
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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