Back to resultsObjective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Primary Purpose
Eyelid Ptoses, Ectropion Eyelids, Entropion;Eye
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Vectra M3 imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Eyelid Ptoses focused on measuring Vectra M3 device, Eyelid Ptoses, stereo photographic system, eyelid surgery
Eligibility 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
Sites / Locations
- University Hospital OstravaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lateral canthal hinge surgery patients
Ptosis surgery patients
Arm Description
Patients undergoing lateral canthal hinge surgery will be enrolled in this group.
Patients undergoing ptosis surgery will be enrolled in this group.
Outcomes
Primary Outcome Measures
Distance between anatomical points on the face
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)
Periorbital volume measurement
In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
Secondary Outcome Measures
The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications
The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed.
Full Information
NCT ID
NCT06040671
First Posted
October 31, 2022
Last Updated
September 8, 2023
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT06040671
Brief Title
Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Official Title
Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Ptoses, Ectropion Eyelids, Entropion;Eye
Keywords
Vectra M3 device, Eyelid Ptoses, stereo photographic system, eyelid surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects will be divided into two groups.
Masking
None (Open Label)
Masking Description
No masking is used in the study.
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lateral canthal hinge surgery patients
Arm Type
Experimental
Arm Description
Patients undergoing lateral canthal hinge surgery will be enrolled in this group.
Arm Title
Ptosis surgery patients
Arm Type
Experimental
Arm Description
Patients undergoing ptosis surgery will be enrolled in this group.
Intervention Type
Other
Intervention Name(s)
Vectra M3 imaging
Intervention Description
Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.
Primary Outcome Measure Information:
Title
Distance between anatomical points on the face
Description
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)
Time Frame
6 months
Title
Periorbital volume measurement
Description
In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications
Description
The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Kopecký, MD,PhD,FEBO
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Adam Kopecký, MD,PhD,FEBO
First Name & Middle Initial & Last Name & Degree
Jan Němčanský, MD,PhD,MBA
First Name & Middle Initial & Last Name & Degree
Václav Dedek, Ing.
First Name & Middle Initial & Last Name & Degree
Jana Dvořáková, Mgr.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.
Learn more about this trial
Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
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