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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral canthal hinge surgery patients | Experimental | Patients undergoing lateral canthal hinge surgery will be enrolled in this group. |
|
| Ptosis surgery patients | Experimental | Patients undergoing ptosis surgery will be enrolled in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vectra M3 imaging | Other | Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Adam Kopecký, MD,PhD,FEBO | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D004483 | Ectropion |
| D004774 | Entropion |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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The study subjects will be divided into two groups.
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No masking is used in the study.
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