Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Societat Catalana d'Oftalmologia | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control grup | Active Comparator | Conventional surgery. |
|
| Intervention group | Experimental | Surgery planned, simulated and guided by 3D printing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printing model/guide. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications | Intraoperative complications | 6 months |
| Postoperative complications | Postoperative complications | 6 months |
| Exophthalmos | Exophthalmos measured in millimeters | 6 months |
| Diplopia | Diplopia correction | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eduard Pedemonte-Sarrias, Md, PhD | Althaia Xarxa Assistencial Università ria de Manresa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eduard Pedemonte Sarrias | Manresa | Barcelona | 08243 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard surgery | Procedure | Orbital decompression surgery will be previously planned and simulated using the actual standard methods. |
|
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |