Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Exophthalmos
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Control grup
Conventional surgery.
Intervention: Standard surgery (Procedure)
Intervention group
Surgery planned, simulated and guided by 3D printing.
Intervention: 3D printing model/guide. (Device)
Outcomes
Primary Outcomes
Exophthalmos
Time Frame: 6 months
Exophthalmos measured in millimeters
Intraoperative complications
Time Frame: 6 months
Intraoperative complications
Postoperative complications
Time Frame: 6 months
Postoperative complications
Diplopia
Time Frame: 6 months
Diplopia correction
Secondary Outcomes
No secondary outcomes reported
Investigators
Eduard Pedemonte-Sarrias
Ophthalmologist, MD, PhD
Althaia Xarxa Assistencial Universitària de Manresa