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

University Hospital Ostrava

Status: Enrolling

Conditions: Ectropion Eyelids; Entropion;Eye; Eyelid Ptoses

Treatments: Other: Vectra M3 imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06040671

28/RVO-FNOs/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Lateral canthal hinge surgery patients

Experimental group

Description:

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

Treatment:

Other: Vectra M3 imaging

Ptosis surgery patients

Experimental group

Description:

Patients undergoing ptosis surgery will be enrolled in this group.

Treatment:

Other: Vectra M3 imaging