Comparative Study and Validation of New Methodologies for Measuring Addition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Subject's age
研究概览
简要总结
The aim of this research is to collect comprehensive data on a presbyopic population that may require near vision correction, in order to identify the most useful tests to accurately determine the value of an addition.
详细描述
Refraction is the key point of an ophthalmic examination when visual correction is required for distance vision, as is determining the addition for near vision. These measurements can be obtained objectively and/or subjectively.
The addition for near vision is most often obtained using so-called subjective devices, i.e., by relying on the patient's responses.
The state of the accommodative system can, however, be measured objectively using instruments available to prescribers (retinoscopes, automatic refractometers, aberrometers, etc.). These measurements can be used in clinical practice as a solid basis for the initial assessment of the subject's refractive status during a comprehensive eye examination. However, these measurements are not sufficient to determine the optimal correction to prescribe for near vision, i.e., one that achieves sufficient visual acuity and comfort to ensure effectiveness for the tasks a person wishes to perform in their daily life.
Indeed, subjective tests are considered the gold standard for prescribers, particularly when it comes to near vision testing. Also, there are numerous procedures for determining the appropriate addition to prescribe, and a wide variety of practices is observed among prescribers around the world. It is often necessary to perform multiple tests to ensure the correct addition value to recommend.
The aim of this study is to find ways of approaching the value of the ideal addition as accurately as possible, based on several parameters: measurements representative of subjects' near vision habits, optometric measurements to determine near vision addition, and measurements related to binocular vision and symptomatology. This data collection will enable to identify the most effective combination of measurements in order to determine the optimal near vision addition for a subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
- •Aged 40 to 60 years
- •Individual with monocular visual acuity ≥ +0.1 LogMAR with current corrections and pinhole if necessary
- •Individual with a visual acuity difference ≤ 0.2 LogMAR with current corrections
- •Individual with stable binocular vision in distance and near vision
排除标准
- •Age < 40 years (i.e., no minors in accordance with Article L1121-7)
- •Age > 60 years
- •All categories of people specifically protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code):
- •Pregnant, childbearing, or breastfeeding women (Article L1121-5)
- •Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research
- •Adults incapable or unable to express consent (Article L1121-8)
- •Participants currently excluded from another study
- •Participants unable to be contacted in case of emergency
- •Person with strabismus
- •Person with amblyopia
- •Aphakic or pseudophakic person
- •Person with vertical phoria > 1 PD
- •Declared neurological deficit, including a history of epileptic disorders or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders)
- •Declared severe ocular pathology, involving visual field loss, such as glaucoma, or involving loss of acuity and significant discomfort in dimly or excessively lit environments, such as retinitis pigmentosa, or declared and treated dry eye.
研究组 & 干预措施
Validation of new addition measurement methodologies
干预措施: Standard Subjective refraction (Device)
Validation of new addition measurement methodologies
干预措施: Visual Acuity (Device)
Validation of new addition measurement methodologies
干预措施: Objective refraction (Device)
Validation of new addition measurement methodologies
干预措施: Near vision examination and determination of additions (Device)
Validation of new addition measurement methodologies
干预措施: Binocular vision tests (Device)
Validation of new addition measurement methodologies
干预措施: Extended trial of addition (Device)
结局指标
主要结局
Subject's age
时间窗: Day 1
The subject's age is requested via the Case Report Form
Addition value given by the objective method
时间窗: Day 1
When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an auto-kerato-refractometer/aberrometer. It is an objective measure because it does not call upon the subject's responses when presented with acuity scales.
Addition value given by the subjective method
时间窗: Day 1
When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an autorefractometer. It is a subjective measure because it calls upon the subject's responses when presented with acuity scales.
Working distances for near vision
时间窗: Day 1
Several working distances are measured for near vision. The values of the distances are expressed in centimeters (cm). The various working distances for near vision are: * Harmon distance: the morphological distance from the elbow to the clenched fist * Revip distance (visuo-postural reflex): the subject is given a blank A4 sheet of paper and asked to hold it at their potential reading distance. * Desired distance: the distance at which a subject can read a Times 12 text on an A4 sheet of paper.
次要结局
- Quality of Vision questionnaire (Qov) score(Day 1)
- CISS questionnaire (Convergence Insufficiency Symptom Survey) score(Day 1)