Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Periorbital volume measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking is used in the study.
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyelid ptosis
- •Eyelid entropion
- •Eyelid ectropion
排除标准
- •Refusal to participate in the study
- •Not signing the Informed Consent Form
- •Inability/reluctance to cooperate in the study
结局指标
主要结局
Periorbital volume measurement
时间窗: 6 months
In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
Distance between anatomical points on the face
时间窗: 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)
次要结局
- The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications(3 years)