Intermediate Vision in a Driving Simulator Environment: Comparison of the New J&J EYHANCE IOL With a Conventional Monofocal IOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- logVA
研究概览
简要总结
To compare (low contrast) visual acuity (VA) and contrast sensitivity (CS) - both at intermediate distances under nighttime driving conditions in a driving simulator between patients with bilateral EYHANCE IOLs OR bilateral conventional monofocal IOLs. Visual function testing in the driving simulator will be assessed without AND with (static) glare.
Additionally: Assessment of individual response times, scanpath characteristics, evaluation of test retest reliability and self-evaluation of (intermediate) vision and visual impairment related to glare.
详细描述
To compare (low contrast) visual acuity (VA) and contrast sensitivity (CS) - both at intermediate distances under nighttime driving conditions in a driving simulator between patients with bilateral EYHANCE IOLs OR bilateral conventional monofocal IOLs. Visual function testing in the driving simulator will be assessed without AND with (static) glare.
Additionally: Assessment of individual response times, scanpath characteristics, evaluation of test retest reliability and self-evaluation of (intermediate) vision and visual impairment related to glare.
Simulator
Patients are instructed to drive with a constant speed of 40 km/h on a virtual parcours (straight lane). For testing of either (low contrast) visual acuity or contrast sensitivity, 8-position LANDOLT C's are presented at three locations (within the simulator car, AUDI A4, Ingolstadt/FRG):
(i) At the center of the instrument panel (distance 0.xx m) (ii) At the center of the navigation monitor (y.yy m) (iii) At the center of the rear monitor (z.zz m) A high resolution acoustic attention guidance for immediate gaze direction of the patients towards the three above-mentioned visual stimulus locations (i-iii) is mandatory.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •S.p. (at least two months post surgery) bilateral uneventful IOL surgery (bilateral implantation of either EYHANCE IOL OR monofocal IOL)
- •Ophthalmological history normal, except cataract and uneventful IOL surgery
- •Distant visual high-contrast acuity > 20/25 in either eye
- •Normal stereopsis (all figures of the LANG I random dot stereo test correctly recognized)
排除标准
- •Age below 18 years
- •Chronic eye disease (except cataract)
- •History of ocular surgery (except complication-free IOL surgery)
- •Visual pathway lesions
- •Strabismus
结局指标
主要结局
logVA
时间窗: at least two months after uneventful intraocular lens implantation
logarithm of visual acuity at preset low contrast level of 1:2.7 (logCS = 0.2)
logCS
时间窗: at least two months after uneventful intraocular lens implantation
logarithm of contrast sensitivity at a preset visual acuity level of 0.1 (= 2/20)
次要结局
- Scanpath characteristics (IV)(at least two months after uneventful intraocular lens implantation)
- Self-evaluation (questionnaire) (i) glare sensitivity with best distant correction(at least two months after uneventful intraocular lens implantation)
- Self-evaluation (questionnaire) (i) intermediate vision with best distant correction(at least two months after uneventful intraocular lens implantation)
- Self-evaluation (questionnaire) (i) General post-op vision with best distant corr.(at least two months after uneventful intraocular lens implantation)
- Scanpath characteristics (I)(at least two months after uneventful intraocular lens implantation)
- Scanpath characteristics (II)(at least two months after uneventful intraocular lens implantation)
- Scanpath characteristics (III)(at least two months after uneventful intraocular lens implantation)
- Reproducibilities of logVA(at least two months after uneventful intraocular lens implantation)
- Self-evaluation (questionnaire) (i) mesopic vision with best distant correction(at least two months after uneventful intraocular lens implantation)
- Resonse times of logCS(at least two months after uneventful intraocular lens implantation)
- Self-evaluation (questionnaire) (i) distant vision with best distant correction(at least two months after uneventful intraocular lens implantation)