Feasibility Study of Tests, on the Model of Real-life Daily Tasks, Measuring the Performance of Different Vision Restoration Strategies, After Cataract Surgical Treatment With Different Types of Intraocular Lens Implants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Locomotion - Guided walk
研究概览
简要总结
Prospective, interventional, non-invasive, monocentric, longitudinal, non-randomized study
详细描述
There are many strategies for restoring vision after cataract surgery. They all involve the use of intraocular lenses (IOLs) to correct a single focal length (monofocal lenses) or several focal lengths (multifocal lenses). Each focal length corrected by the implants represents a distance of clear vision for patients. The complexity of the optical design and the neurosensory adaptation required for this restoration may present a downside, as implant patients may complain of light halos, glare or problems with depth perception, depending on the case.
Existing validated techniques are not sufficient to accurately assess the benefits or difficulties in the daily lives of elderly patients, the a With this project, the patient and his or her autonomy become the focus of the evaluation of IOL performance, particularly for IOLs of recent design, which makes it possible to better characterise the consequences of their implantation. PerfO studies of IOLs used in cataract surgery will be based on objectives tasks inspired by daily life performed by patients according to Street Lab procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male / Female
- •65-75 years old
- •Pseudophakia, implanted with 2 trifocal IOL or 2 EDOF IOL or with 2 monofocal IOL calculated for monovision
- •Second eye surgery performed > 1 month before inclusion with stable residual refraction
- •No degenerative or neurological disease
- •Good understanding of the French language
- •No use of an aid to locomotion (example: cane, etc...)
- •Binocular far non corrected visual acuity ≥ 8/10
- •Refraction at distance vision
- •Spherical equivalent in distance vision ≤ 0.75 diopter
- •Cylinder ≤ 0.75 diopter
- •Monovision group :
- •> Addition=1.25 diopter ±0.50
- •Multifocal group :
- •Monocular far non corrected visual acuity ≥ 8/10
- •ATLISA tri (Zeiss)
- •EDOF group :
- •Monocular far non corrected visual acuity ≥ 8/10
- •Eyehance (J&J)
排除标准
- •Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
- •Media opacity or eye movement disorder (nystagmus) that interferes with retinal imaging data quality in the opinion of the investigator ;
- •Any concurrent intraocular condition that, in the opinion of the investigator would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results ;
- •Known systemic illness which in the opinion of the investigator will prevent from actively participating in the study ;
- •Concomitant treatment in either eye (concomitant use of vitamins/supplements is not excluded) ;
- •Inability to comply with study task instructions or study visits ;
- •Medication that may cause motor, visual or cognitive impairment (PSAs, neuroleptics, etc.) or interfere with study evaluations ;
- •Other uncontrolled ophthalmic conditions that may interfere with study evaluation ;
- •Participation in another clinical trial that may interfere with the present study ;
- •Cognitive impairment, illiteracy, and subjects who do not speak the national language ;
- •Paralysis may compromise ability to perform manual grasping tasks ;
- •Pregnant or breastfeeding woman ;
- •Patient under legal protection ("curatelle" or "tutelle") ;
- •Patient denied freedom by a legal or administrative order.
结局指标
主要结局
Locomotion - Guided walk
时间窗: 3 months
The operator measure the success and completion rates for daily life tests: The performance is measured with the walking speed and the foot placement precision. The walking balance is also evaluated by recording the pelvis position.
Static and dynamic posturography with optical flow:
时间窗: 3 months
Postural control will be described by the Root Mean Square (RMS) of body sway in sagittal and coronal plans, the path length of the projection of the center of mass (CoM), the sway area described by the confidence ellipse which is the region that contains 95% of all COM samples. To better understand the visual, vestibular and somatosensory contributions on postural control, Romberg quotient (QR), Visual ratio (ViR), vestibular ratio (VeR) and somatosensory ratio (SR) will be calculated thanks to sensory conditions. Correlations with visual functions will be realized and postural deficits will be integrated into the locomotion score as a covariable.
Visuo-manual task
时间窗: 3 months
The variables analyzed :the duration of the visual search, which will be an indicator of the quality and ease of vision ; the duration of the grasping movement, which will be an indicator of the ease of the approach movement towards a low contrast object ; the duration between the seizure of the object and its deposit, which will be an indicator of the sensitivity to contrast ; the number of errors (wrong object grasped, object dropped, ...), will be an indicator of insufficient vision to perform the task.
Quality of life
时间窗: 3 months
French version Adapted Catquest-9SF questionnaire. It is a psychometric questionnaire specifically designed for cataracts. It assesses patient satisfaction with their eyesight. It consists of nine questions divided into two parts. The first part concerns two questions on the general quality of vision perceived by the patient, and the second part concerns seven questions on the difficulties that vision can cause on daily activities. The first page contains an explanatory note on the questionnaire. The patients' answers are divided into four equal boxes designating the degree of difficulty: very great difficulty, great difficulty, moderate difficulty and no difficulty.
次要结局
未报告次要终点