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Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.

Sponsor
Althaia Xarxa Assistencial Universitària de Manresa (Other)
Overall Status
Recruiting
CT.gov ID
NCT04662190
Collaborator
Societat Catalana d'Oftalmologia (Other)
12
Enrollment
1
Location
2
Arms
15.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 3D printing model/guide.
  • Procedure: Standard surgery
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 5, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control grup

Conventional surgery.

Procedure: Standard surgery
Orbital decompression surgery will be previously planned and simulated using the actual standard methods.
Experimental: Intervention group

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.

Outcome Measures

Primary Outcome Measures

  1. Intraoperative complications [6 months]

    Intraoperative complications

  2. Postoperative complications [6 months]

    Postoperative complications

  3. Exophthalmos [6 months]

    Exophthalmos measured in millimeters

  4. Diplopia [6 months]

    Diplopia correction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eduard Pedemonte Sarrias Manresa Barcelona Spain 08243

Sponsors and Collaborators

  • Althaia Xarxa Assistencial Universitària de Manresa
  • Societat Catalana d'Oftalmologia

Investigators

  • Principal Investigator: Eduard Pedemonte-Sarrias, Md, PhD, Althaia Xarxa Assistencial Universitària de Manresa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eduard Pedemonte-Sarrias, Ophthalmologist, MD, PhD, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier:
NCT04662190
Other Study ID Numbers:
  • CEI 20-16
First Posted:
Dec 10, 2020
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy

Study Results

No Results Posted as of Mar 10, 2022