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临床试验/NCT05516160
NCT05516160Unknown不适用

Perceptually Calibrated Scale of Optical Aberrations, Generated by Multifocal Corrective Lenses

Military Institute od Medicine National Research Institute0 个研究点目标入组 20 人开始时间: 2022年9月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
主要终点
presence of optical aberrations in analyzed eyes

研究概览

简要总结

The main objective of the project is to develop a new, more reliable method of modeling and parametrization of the halo and glare phenomena based on the subjective perception of these visual disturbances. The project will consist of three parts. The first will include the psychophysical measurement of glare and halo phenomena perceived by people with multifocal corrective lenses compared to the reference group. The second part will focus on the development of an algorithm for the generation of optical elements (masks) inducing standard halo and glow effects of a given size and intensity. The third phase of the project will concern the calibration of the developed algorithm. For this purpose, the halo and glare will be induced by the developed masks in the healthy eye, so as to match them with the vision disorders measured in the first part of the project in people using multifocal vision correction methods. As a result of this research, a scale for precise measurement of subjective halo and glare phenomena in the field of view will be created, independently covering their intensity and size, and in the future allowing for optical (and not graphic simulation as in commercially available simulators) simulation of scenes seen by patients.

详细描述

CONTENT DESCRIPTION OF THE PROJECT Perceptually calibrated scale of optical aberrations, generated by multifocal corrective lenses Scientific background:As a result of the progressive aging of the population, especially in developed countries, more and more economically active people function after cataract surgery. In Poland, approximately 250,000 patients are eligible for such a procedure annually. During it, the natural lens of the eye with a significantly limited transparency is replaced with an artificial implant, which causes the loss of eye accommodation. In order to ensure full functional vision (near, indirect and far vision), the most commonly used are implants in the form of multifocal lenses, which have become the subject of intensive research in visual optics and optometry in recent years . The search for optimal solutions to compensate for the lack of accommodation is a kind of compromise between the depth of field of view and its resolution and contrast. Often, a side effect of increasing the range of viewing distances turns out to be various types of aberrations causing distortions of the seen scenes in the form of glare and halo The glare and halo phenomena are a natural consequence of the optical properties of multifocal lenses, i.e. lenses that create two or more foci of light focus along the optical axis. Such lenses allow for sharp imaging on the screen of the retina of the eye at the same time of objects from several distances. A focused image of a point object (strictly of small angular size) placed at one of the design distances is blurred in the other. An intense bright spot (glow) appears in the center surrounded by rings of light (halo). In daytime vision, the visual centers in the human brain are shown to be good at suppressing the perception of these disturbances. The problem appears in night vision, however, when the scenes consist of light sources (lanterns, car lights, reflections) with high contrast to the background. Visible glare and halo phenomena significantly increase the threshold brightness of noticeable objects in the immediate vicinity of bright points of the field of view. Therefore, they seriously limit the safety of participation in road traffic and the comfort of vision after dark.

There are many works devoted to the problem of measuring and parametrization of the halo and glow phenomena. The first approach is based on the optical parameterization of the impulse response (PSF) and modulating transport function (MTF) of the lenses and, on their basis, the visualization of undesirable aberrations. This approach requires the use of the eye model, which is always the result of some simplifications and idealizations. It also does not take into account the physiological processes related to the vision process. Nevertheless, it allows to objectively predict the occurrence of glare and halo phenomena and associate them with a specific design of a corrective lens. It also allows to measure the size and intensity of these effects using variously defined metrics.

The second approach is to try to measure the subjective perception of halo and glow phenomena among patients with implanted or inserted multifocal lenses (Halo & Glare Simulator; Eyeland-Design Network GmbH, Vreden, Germany). Such analyzes are most often based on the method of questionnaires in which the respondents themselves determine the type of visual disturbance (from a closed graphic list) and its degree (on a quantitative scale). The task of assessing visual sensations on an interval scale is a difficult and imprecise task. Therefore, it is undoubtedly necessary to develop a more reliable, based on psychophysical methodology, quantification of the size and intensity of undesirable phenomena in the field of view.

One of the methods combining the objectivity of the study with the subjectivity of phenomena available only to the examined person is the commercially available C-quant device by Oculus (Oculus Optikgeräte, GmbH, Wetzlar, Germany), used for the diagnostic measurement of distractions in night vision. The compensatory comparison method implemented in the device consists in finding such the intensity of the flickering area located in the center of the field of view to compensate for the glow caused by the bright ring flickering in the counter-phase. With appropriately selected light intensities in the center of the field of view, the glow from the ring is visible for half a period, and a target of the same brightness for the second half of the period, so the flickering disappears. The disadvantage of this method is the result in the form of a single parameter by means of which it is impossible to precisely and independently parametrize the halo and glow phenomena.

Another method, used in the Vision Monitor device (MonCv3; Metrovision, Pérenchies, France), is a study in which the patient reads optotypes with a specific contrast placed at an increasing distance from a point light source [6]. Since the light source creates a glow and a halo in the field of view of the examined person, the minimum brightness of the identifiable individual optotypes differs depending on the distance from it. Measurement of this brightness allows to parameterize - in the analyzed device with relatively low resolution - the glow and halo phenomena in the form of their profile and intensity depending on the distance from the light source. A similar methodology will be used in the project requested for funding.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult males and females, of any race
  • one or both eyes with implanted intraocular monofocal lens (10 eyes) and multifocal lens (10 eyes)
  • informed consent to participate in the study
  • presence at scheduled follow-up visits after the procedure for a period of 24 months.

排除标准

  • in the eye qualified for the test:
  • Fuchs dystrophy and other corneal diseases
  • evidence of serious eye disease
  • ophthalmic surgeries other than cataract surgery
  • clinically active or past uveitis
  • intraocular pressure (IOP) >21 mmHg
  • retinal detachment or its suspicion in ultrasound examination of the eyeball
  • systemic diseases with ocular symptoms, including diseases that may affect the function of corneal endothelial cells
  • intolerance of the examination in the slit lamp or other procedures planned in the examination
  • pregnancy
  • mental disorders or emotional instability to an extent that does not allow the subject's informed consent in the study and presence at scheduled follow-up visits
  • documented sensitivity to pharmacological agents used in the study, i.e. topical anesthetics, fluorescein, other related to the ophthalmological examination serious fatal illnesses or a patient's medical condition preventing the study from continuing for a period of 6 months
  • current participation in other research programs
  • therapy with oral anticoagulants
  • the participant may withdraw from the study at any time and for any reason without consequences and without prohibiting participation in other research projects. A participant may not return to the current study again if he or she has previously withdrawn.
  • Termination of participation in the study may take place in the case of:
  • decrease in visual acuity >3 Snellen lines from baseline (> 15 letters ETDRS, >0.3 logMAR) in one of the eyes
  • the presence of adverse symptoms or complications associated or not with the examination, which affect the ability to see or the functioning of the body.

结局指标

主要结局

presence of optical aberrations in analyzed eyes

时间窗: up to 3 months

halo and glare presence in analyzed eyes

次要结局

未报告次要终点

研究者

发起方
Military Institute od Medicine National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karolina Krix-jachym

Principal Investigator

Military Institute od Medicine National Research Institute

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