Thyroid Associated OphthalmopathyNCT04662190
Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.
A study testing 3D printing model/guide. and Standard surgery in people with Thyroid Associated Ophthalmopathy and Surgical Procedure, Unspecified, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Associated Ophthalmopathy, Surgical Procedure, Unspecified
- What is being tested?
- 3D printing model/guide. and Standard surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2021to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Younger than 18 years old.
- Previous orbital surgery.
- Any coexisting disease preventing follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.
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.
- Being tested
- 3D printing model/guide., Standard surgery
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard surgeryProcedure or surgery
Orbital decompression surgery will be previously planned and simulated using the actual standard methods.
| Study group | Role | What they receive |
|---|---|---|
| Control grup | Active comparator | Conventional surgery. Receives: Procedure: Standard surgery |
| Intervention group | Experimental | Surgery planned, simulated and guided by 3D printing. Receives: Device: 3D printing model/guide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative complications
Intraoperative complications
Measured: 6 months
Postoperative complications
Postoperative complications
Measured: 6 months
Exophthalmos
Exophthalmos measured in millimeters
Measured: 6 months
Diplopia
Diplopia correction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start5 Jul 2021
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Associated OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana d'Oftalmologia
- Responsible party
- Principal investigator, Eduard Pedemonte-Sarrias, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Eduard Pedemonte-Sarrias, Md, PhD, Principal investigator, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662190
- Sponsor's protocol ID
- CEI 20-16
- Status last verified
- May 2026
- First submitted
- 6 Dec 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.
- ClinicalTrials.gov ID
- NCT04662190
- Acronym / sponsor ID
- CEI 20-16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Collaborators
- Societat Catalana d'Oftalmologia
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control grup | Active comparator | Procedure: Standard surgeryConventional surgery. |
| Intervention group | Experimental | Device: 3D printing model/guide.Surgery planned, simulated and guided by 3D printing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Younger than 18 years old.
- Previous orbital surgery.
- Any coexisting disease preventing follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention group |
| Standard surgeryOrbital decompression surgery will be previously planned and simulated using the actual standard methods. | Procedure or surgery | Control grup |
Primary outcome
Intraoperative complications
Time frame: 6 months
Intraoperative complications
Postoperative complications
Time frame: 6 months
Postoperative complications
Exophthalmos
Time frame: 6 months
Exophthalmos measured in millimeters
Diplopia
Time frame: 6 months
Diplopia correction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Pedemonte-Sarrias, Md, PhD principal investigator
Althaia Xarxa Assistencial Universitària de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing model/guide. and Standard surgery in people with Thyroid Associated Ophthalmopathy and Surgical Procedure, Unspecified, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative complications (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.