Ectropion Eyelids, Entropion;Eye, Eyelid Ptoses
Conditions
Keywords
Vectra M3 device, Eyelid Ptoses, stereo photographic system, eyelid surgery
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.
Interventions
OTHERVectra M3 imaging
Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.
Sponsors
University Hospital Ostrava
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking is used in the study.
Intervention model description
The study subjects will be divided into two groups.
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Periorbital volume measurement | 6 months | In all patients, the periorbital volume (volume in mm3) will be assessed metrically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed