The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06040671
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
An objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that focuses on correcting the position of entropy (e.g. ectropion, ptosis surgery) is very difficult - although it is possible to use different measuring parameters (distance of pupillary reflexes from the edges of the eyelid), comparing different distances on the face, exophthalmometry or the lid laxity test - the so-called snap-back test, but all these methods are based either on the subjective assessment of the examiner or on the correctness of the attached ruler, and their objectivity is therefore very low.

Condition or disease Intervention/treatment Phase
Eyelid Ptoses Ectropion Eyelids Entropion;Eye Other: Vectra M3 imaging Not Applicable

Detailed Description:

The goal of the project is to develop a methodology for evaluating the results of operations using a stereo photographic system, to objectively evaluate the functionality and results of various eyelid operations, and subsequently to expand the use of the device in other ophthalmological indications.

Different files will be created where the effect of different operations will be monitored in parallel.

Lateral canthal hinge surgery will be evaluated in the pilot group, and ptosis surgery through an anterior approach will be evaluated in the second group.

In all patients, the position of the eyelids, their change before and after surgery, the periorbital volume, and the relation of the eyelids to the periorbital landscape will be assessed metrically.

The Vectra M3 device will be used for the measurement.

The expected cohort size is 40 patients in each group.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study subjects will be divided into two groups.
Masking: None (Open Label)
Masking Description: No masking is used in the study.
Primary Purpose: Diagnostic
Official Title: Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Lateral canthal hinge surgery patients
Patients undergoing lateral canthal hinge surgery will be enrolled in this group.
 Other: Vectra M3 imaging
Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.
Experimental: Ptosis surgery patients
Patients undergoing ptosis surgery will be enrolled in this group.
 Other: Vectra M3 imaging
Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Distance between anatomical points on the face [ Time Frame: 6 months ]
    In all patients, distance between 52 anatomical-topographical points on the face will be measured in millimetres (mm) - change of the position of the eyelids before and after surgery (distance in mm), the relation of the eyelids to the periorbital landscape (distance in mm)

  2. Periorbital volume measurement [ Time Frame: 6 months ]
    In all patients, the periorbital volume (volume in mm3) will be assessed metrically.


Secondary Outcome Measures :
  1. The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications [ Time Frame: 3 years ]
    The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eyelid ptosis
  • Eyelid entropion
  • Eyelid ectropion

Exclusion Criteria:

  • Refusal to participate in the study
  • Not signing the Informed Consent Form
  • Inability/reluctance to cooperate in the study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040671


Contacts
Layout table for location contacts
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
Layout table for location information
Czechia
University Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 70852
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Adam Kopecký, MD,PhD,FEBO         
Sub-Investigator: Jan Němčanský, MD,PhD,MBA         
Sub-Investigator: Václav Dedek, Ing.         
Sub-Investigator: Jana Dvořáková, Mgr.         
Sponsors and Collaborators
University Hospital Ostrava
Investigators
Layout table for investigator information
Principal Investigator: Adam Kopecký, MD,PhD,FEBO University Hospital Ostrava
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT06040671    
Other Study ID Numbers: 28/RVO-FNOs/2021
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Ostrava:
Vectra M3 device
Eyelid Ptoses
stereo photographic system
eyelid surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Entropion
Ectropion
Blepharoptosis
Eyelid Diseases
Eye Diseases