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

September 8, 2023 updated by: University Hospital Ostrava
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Sub-Investigator:
          • Jan Němčanský, MD,PhD,MBA
        • Principal Investigator:
          • Adam Kopecký, MD,PhD,FEBO
        • Sub-Investigator:
          • Václav Dedek, Ing.
        • Sub-Investigator:
          • Jana Dvořáková, Mgr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months
Periorbital volume measurement
Time Frame: 6 months
In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Adam Kopecký, MD,PhD,FEBO, University Hospital Ostrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28/RVO-FNOs/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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