Assessment of Vivity With French Clinical Data Related to the Toric Model Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 主要终点
- Distance corrected intermediate monocular visual acuity
研究概览
简要总结
Presbyopia-correcting implant (PC-IOL): AcrySof IQ Vivity (Alcon) has been evaluated in 2 large pivotal trials (US and OUS trials). These tests showed that this PC-IOL restored intermediate visual acuity (IVA) and near visual acuity (NV A) superior to that of the reference monofocal AcrySof implant. In these tests, it was demonstrated that distance visual acuity (DVA) was non-inferior. However, the intermediate visual acuity for this implant in its toric version has not been evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient presenting for a request for cataract surgery in current practice: phacoemulsification followed by classic implantation of an IOL with small incision size (< 2.2mm)
- •Calculated power of IOL is between 10.0 and 30.0 diopters (D) in 0.5D steps to target emmetropia (0.0 +/- 0.5D)
- •Patients with corneal astigmatism > 0.5D and who can receive an implant with a toricity between T2 and T6, i.e. with astigmatism between +0.5D and +2.5D.
- •If both eyes have astigmatism, the eye under study will be the right eye
- •Patient having been informed and not objecting to their participation.
排除标准
- •Pregnancy or breastfeeding while conducting the study
- •Person under the age of 18
- •History of pathologies of the anterior segment of the eye (cornea, anterior chamber, sulcus) or posterior segment of the eye (uvea, vitreous, retina) including retinal vascular occlusions, retinal detachment, peripheral retinal laser photocoagulation, AMD and glaucoma
- •Any inflammation of the anterior or posterior segment, whatever its etiology or history of disease, which may lead to an inflammatory reaction
- •Clinically significant corneal pathology (epithelial, stromal, or endothelial that could affect visual outcome)
- •Clinically significant severe dry eye disease that may affect visual calculations and measurements
- •History of refractive surgery
- •Amblyopia or monofixation syndrome
- •Patient at risk of zonular rupture during the phacoemulsification procedure and may affect the centering or tilt of the implant postoperatively.
- •Irregular astigmatism (corneal topography)
- •Any other planned eye surgery
结局指标
主要结局
Distance corrected intermediate monocular visual acuity
时间窗: month 3
Intermediate monocular visual acuity (at 66 cm) corrected for distance vision (DCIVA) for the eye under study in photopic condition (normal lighting) 3 months after implantation of the 2nd eye
次要结局
- residual astigmatism(months 1 and 3)
- monocular distance visual acuity(months 1 and 3)
- binocular uncorrected visual acuity(months 1 and 3)
- rotational stability(month 3)
- monocular near visual acuity(months 1 and 3)
- SIA(month 3)
- monocular uncorrected intermediate visual acuity(months 1 and 3)
- questionnaire IOLSAT(month 3)
- McAlinden questionnaire(month 3)
研究者
Edouard KOCH
Investigator Coordinator
Versailles Hospital