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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Eyelid Ptoses, Ectropion Eyelids, Entropion;Eye

Intervention / Treatment
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* Other: Vectra M3 imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study subjects will be divided into two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lateral canthal hinge surgery patients<br>Patients undergoing lateral canthal hinge surgery will be enrolled in this group. | Other: Vectra M3 imaging<br>* Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.<br>|
| Experimental: Ptosis surgery patients<br>Patients undergoing ptosis surgery will be enrolled in this group. | Other: Vectra M3 imaging<br>* Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months | 
| Periorbital volume measurement | 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 | The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vectra M3 device, Eyelid Ptoses, stereo photographic system, eyelid surgery