An interventional study of 3D printing model/guide. and Standard surgery in Thyroid Associated Ophthalmopathy and Surgical Procedure, Unspecified, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Not applicable, Interventional, and Treatment
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.
199 studies on the registry are indexed under Graves Ophthalmopathy; 58 are open to participants now.
This study's enrollment of 12 is below the median of 63 across 146 interventional studies indexed under Graves Ophthalmopathy.
Browse Graves Ophthalmopathy studies →Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional surgery.
Procedure: Standard surgery
Surgery planned, simulated and guided by 3D printing.
Device: 3D 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.
Orbital decompression surgery will be previously planned and simulated using the actual standard methods.
Intraoperative complications
Intraoperative complications
Time frame: 6 months
Postoperative complications
Postoperative complications
Time frame: 6 months
Exophthalmos
Exophthalmos measured in millimeters
Time frame: 6 months
Diplopia
Diplopia correction
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Mar 2026, 56 months.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Althaia Xarxa Assistencial Universitària de Manresa