Status:
RECRUITING
Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.
Lead Sponsor:
Althaia Xarxa Assistencial Universitària de Manresa
Collaborating Sponsors:
Societat Catalana d'Oftalmologia
Conditions:
Thyroid Associated Ophthalmopathy
Surgical Procedure, Unspecified
Eligibility:
All Genders
18+ years
Phase:
NA
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-a...
Eligibility Criteria
Inclusion
- 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
- Younger than 18 years old.
- Previous orbital surgery.
- Any coexisting disease preventing follow-up.
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04662190
Start Date
July 5 2021
End Date
June 1 2026
Last Update
January 31 2025
Active Locations (1)
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1
Eduard Pedemonte Sarrias
Manresa, Barcelona, Spain, 08243