Using 3D printing to improve orbital surgery for thyroid eye disease
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 study is testing whether using 3D printed models can help doctors perform better surgeries for people with thyroid eye disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Althaia Xarxa Assistencial Universitària de Manresa Academic / other |
| Locations | 1 site (Manresa, Barcelona) |
| Trial ID | NCT04662190 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of using 3D printing technology to plan and simulate orbital decompression surgery for patients with thyroid-associated orbitopathy. It is a multicentric, randomized, single-blinded trial that aims to enhance surgical outcomes by providing personalized surgical guides based on individual patient anatomy. Participants will undergo standard surgical procedures with the aid of 3D printed models to assess improvements in surgical precision and recovery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with inactive thyroid-associated orbitopathy requiring bilateral orbital decompression.
Not a fit: Patients under 18, those who have had previous orbital surgery, or those with coexisting diseases that hinder follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer surgical outcomes for patients with thyroid-associated orbitopathy.
How similar studies have performed: While the use of 3D printing in surgery is gaining traction, this specific application for orbital decompression surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Manresa, Barcelona
- Eduard Pedemonte Sarrias — Manresa, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Eduard Pedemonte-Sarrias, Md, PhD — Althaia Xarxa Assistencial Universitària de Manresa
- Study coordinator: Eduard Pedemonte-Sarrias, MD, PhD
- Email: epedemonte@althaia.cat
- Phone: +34678091233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.