Thyroid Associated Ophthalmopathy, Surgical Procedure, Unspecified
Conditions
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.
Interventions
DEVICE3D 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.
PROCEDUREStandard surgery
Orbital decompression surgery will be previously planned and simulated using the actual standard methods.
Sponsors
Societat Catalana d'Oftalmologia
Althaia Xarxa Assistencial Universitària de Manresa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative complications | 6 months | Intraoperative complications |
| Postoperative complications | 6 months | Postoperative complications |
| Exophthalmos | 6 months | Exophthalmos measured in millimeters |
| Diplopia | 6 months | Diplopia correction |
Countries
Spain
Contacts
Primary ContactEduard Pedemonte-Sarrias, MD, PhD
Backup ContactAnna Arnau, PhD
Outcome results
None listed