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

NCT04662190 | Recruiting

• 1 other identifier: CEI 20-16
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Intraoperative complications

  Intraoperative complications

  6 months

• Postoperative complications

  Postoperative complications

  6 months

• Exophthalmos

  Exophthalmos measured in millimeters

  6 months

• Diplopia

  Diplopia correction

  6 months

Study Arms (2)

Control grup

ACTIVE COMPARATOR

Conventional surgery.

Procedure: Standard surgery

Intervention group

EXPERIMENTAL

Surgery planned, simulated and guided by 3D printing.

Device: 3D printing model/guide.

Interventions

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.

Intervention group

Standard surgery PROCEDURE

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

Control grup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Younger than 18 years old.
• Previous orbital surgery.
• Any coexisting disease preventing follow-up.

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead
• Societat Catalana d'Oftalmologia: collaborator

Study Sites (1)

Eduard Pedemonte Sarrias

Manresa, Barcelona, 08243, Spain

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eduard Pedemonte-Sarrias, Md, PhD

  Althaia Xarxa Assistencial Universitària de Manresa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduard Pedemonte-Sarrias, MD, PhD

CONTACT

+34678091233; epedemonte@althaia.cat

Anna Arnau, PhD

CONTACT

aarnau@althaia.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist, MD, PhD

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 10, 2020
• Study Start: July 5, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)