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

Not Applicable

Recruiting

• Conditions: Eyelid Ptoses; Ectropion Eyelids; Entropion;Eye
• Interventions: Other: Vectra M3 imaging

• Registration Number: NCT06040671
• Lead Sponsor: University Hospital Ostrava

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.

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2022-10-31
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateral canthal hinge surgery patients	Vectra M3 imaging	Patients undergoing lateral canthal hinge surgery will be enrolled in this group.
Ptosis surgery patients	Vectra M3 imaging	Patients undergoing ptosis surgery will be enrolled in this group.

Primary Outcome Measures

Name	Time	Method
Periorbital volume measurement	6 months	In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
Distance between anatomical points on the face	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)

Secondary Outcome Measures

Name	Time	Method
The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications	3 years	The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia