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

NCT ID: NCT06040671

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2023-12-31

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.

Conditions

Eyelid Ptoses; Ectropion Eyelids; Entropion;Eye

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lateral canthal hinge surgery patients

Patients undergoing lateral canthal hinge surgery will be enrolled in this group.

Group Type: EXPERIMENTAL

Vectra M3 imaging

Intervention Type: OTHER

Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.

Ptosis surgery patients

Patients undergoing ptosis surgery will be enrolled in this group.

Group Type: EXPERIMENTAL

Vectra M3 imaging

Intervention Type: OTHER

Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.

Interventions

Vectra M3 imaging

Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Kopecký, MD,PhD,FEBO

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiří Hynčica

Role: CONTACT

jiri.hyncica@fno.cz

0042059737 ext. 2587

Facility Contacts

Jiří Hynčica

Role: primary

jiri.hyncica@fno.cz

0042059737 ext. 2587

Other Identifiers

28/RVO-FNOs/2021

Identifier Type: -

Identifier Source: org_study_id