Assessment of Vivity With French Clinical Data Related to the Toric Model Study (VICTOR)
2022年8月22日 更新者：Edouard KOCH、Versailles Hospital
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.
研究概览
地位
尚未招聘
条件
研究类型
观察性的
注册 (预期的)
31
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients will be selected from among patients who come for consultation for cataract surgery.
During the inclusion visit, the doctor will inform the patients eligible for the study, and answer all their questions about the objective, the constraints, the foreseeable risks and the expected benefits of the study.
Without opposition from the patient, the doctor will perform the cataract surgery and the data will be collected on D0, M1 and M3.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Distance corrected intermediate monocular visual acuity
大体时间：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
|
month 3
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
rotational stability
大体时间：month 3
|
Rotational stability of the IOL in the eye under study expressed in degree of rotation at 3 months compared with that collected just after surgery in the operating room
|
month 3
|
|
residual astigmatism
大体时间：months 1 and 3
|
measure of total residual astigmatism including corneal and internal astigmatism in dioptries
|
months 1 and 3
|
|
monocular distance visual acuity
大体时间：months 1 and 3
|
Corrected (BCDVA) and uncorrected monocular distance visual acuity (UCDVA) for the study eye (at 4 m)
|
months 1 and 3
|
|
monocular near visual acuity
大体时间：months 1 and 3
|
Corrected (DCNVA) and uncorrected monocular (UCNVA) near visual acuity for the study eye (at 40 cm)
|
months 1 and 3
|
|
monocular uncorrected intermediate visual acuity
大体时间：months 1 and 3
|
Uncorrected intermediate visual acuity monocular (UCIVA) for the eye under study (at 66 cm)
|
months 1 and 3
|
|
binocular uncorrected visual acuity
大体时间：months 1 and 3
|
Binocular uncorrected visual acuity (UCVA) from far to 4 m, intermediate at 66 cm, near at 40 cm.
|
months 1 and 3
|
|
SIA
大体时间：month 3
|
Surgically induced astigmatism (SIA) and comparison between the 2 hospitals participating in the study
|
month 3
|
|
questionnaire IOLSAT
大体时间：month 3
|
questionnaire for addiction to glasses for intermediate vision and near vision (IOLSAT) : minimum 0% (no glasses needed, best outcome), to maximum 100% (glasses needed, worse outcome)
|
month 3
|
|
McAlinden questionnaire
大体时间：month 3
|
questionnaire for the evaluation of visual disturbances (McAlinden): minimum 0/90 and maximum 90/90 (worse outcome)
|
month 3
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年9月1日
初级完成 (预期的)
2023年4月1日
研究完成 (预期的)
2023年7月1日
研究注册日期
首次提交
2022年6月3日
首先提交符合 QC 标准的
2022年6月8日
首次发布 (实际的)
2022年6月13日
研究记录更新
最后更新发布 (实际的)
2022年8月25日
上次提交的符合 QC 标准的更新
2022年8月22日
最后验证
2022年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.