Back to resultsEvaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.
Primary Purpose
Thyroid Associated Ophthalmopathy, Surgical Procedure, Unspecified
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
3D printing model/guide.
Standard surgery
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Associated Ophthalmopathy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Younger than 18 years old.
- Previous orbital surgery.
- Any coexisting disease preventing follow-up.
Sites / Locations
- Eduard Pedemonte SarriasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control grup
Intervention group
Arm Description
Conventional surgery.
Surgery planned, simulated and guided by 3D printing.
Outcomes
Primary Outcome Measures
Intraoperative complications
Intraoperative complications
Postoperative complications
Postoperative complications
Exophthalmos
Exophthalmos measured in millimeters
Diplopia
Diplopia correction
Secondary Outcome Measures
Full Information
NCT ID
NCT04662190
First Posted
December 6, 2020
Last Updated
January 31, 2023
Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
Societat Catalana d'Oftalmologia
1. Study Identification
Unique Protocol Identification Number
NCT04662190
Brief Title
Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Collaborators
Societat Catalana d'Oftalmologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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-associated orbitopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Associated Ophthalmopathy, Surgical Procedure, Unspecified
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control grup
Arm Type
Active Comparator
Arm Description
Conventional surgery.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Surgery planned, simulated and guided by 3D printing.
Intervention Type
Device
Intervention Name(s)
3D printing model/guide.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard surgery
Intervention Description
Orbital decompression surgery will be previously planned and simulated using the actual standard methods.
Primary Outcome Measure Information:
Title
Intraoperative complications
Description
Intraoperative complications
Time Frame
6 months
Title
Postoperative complications
Description
Postoperative complications
Time Frame
6 months
Title
Exophthalmos
Description
Exophthalmos measured in millimeters
Time Frame
6 months
Title
Diplopia
Description
Diplopia correction
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Younger than 18 years old.
Previous orbital surgery.
Any coexisting disease preventing follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduard Pedemonte-Sarrias, MD, PhD
Phone
+34678091233
Email
epedemonte@althaia.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Arnau, PhD
Email
aarnau@althaia.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Pedemonte-Sarrias, Md, PhD
Organizational Affiliation
Althaia Xarxa Assistencial Universitària de Manresa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eduard Pedemonte Sarrias
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Arnau Bartés, PhD
Phone
+34 93 875 93 00
Ext
3414
Email
aarnau@althaia.cat
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.
We'll reach out to this number within 24 hrs