Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Eduard Pedemonte Sarrias
RECRUITING
Manresa
Contact Information
Primary
Eduard Pedemonte-Sarrias, MD, PhD
epedemonte@althaia.cat
+34678091233
Backup
Anna Arnau, PhD
aarnau@althaia.cat
Time Frame
Start Date: 2021-07-05
Estimated Completion Date: 2026-06
Participants
Target number of participants: 12
Treatments
Active_comparator: Control grup
Conventional surgery.
Experimental: Intervention group
Surgery planned, simulated and guided by 3D printing.
Related Therapeutic Areas
Sponsors
Collaborators: Societat Catalana d'Oftalmologia
Leads: Althaia Xarxa Assistencial Universitària de Manresa