NCT05901597已完成不适用
Refractive Accuracy of Argos in Conjunction With the Alcon Vision Suite Following Implantation of Presbyopia Correcting IOLs
Valley Laser Eye Centre1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2023年5月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Monocular refractive target accuracy
研究概览
简要总结
The objective is to assess refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation.
详细描述
This study is a single-arm, observational study of refractive accuracy of the Alcon Vision Suite (with Argos biometer) following Clareon PanOptix and AcrySof Vivity IOL implantation. Subjects will be assessed at preoperatively, operatively, and 10 weeks post-operatively. Clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and questionnaires will also be administered.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in both eyes.
- •Age-related cataract surgery (or RLE) patients that select Clareon PanOptix or AcrySof Vivity IOL.
- •Gender: Males and Females.
- •Age: 45 or older.
- •Patients motivated to increase spectacle independence with relatively low incidence of visual phenomena.
- •Willing and able to provide written informed consent for participation in the study.
- •Willing and able to comply with scheduled visits and other study procedures.
- •Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error).
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Ocular comorbidity (any previous ocular surgery, any signs of retinal disease, or glaucoma etc.) that might hamper post-operative visual acuity.
- •Irregular corneal astigmatism and keratoconus.
- •Post refractive eyes (i.e. LASIK or PRK or SMILE).
- •Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
- •Angle Kappa/chord mu ≥0.
- •Higher order corneal aberrations: > 0.6 total RMS, >0.3 coma, >0.3 trefoil (to exclude irregular corneas).
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Monocular refractive target accuracy
时间窗: 10 Weeks postoperative
Percentage of subjects within predicted postoperative spherical equivalent of ± 0.5 D.
次要结局
- Median absolute prediction error(10 Weeks postoperative)
- Back-calculated Residual Astigmatism (BRA)(10 Weeks postoperative)
- Distance corrected monocular visual acuity(10 Weeks postoperative)
- Prediction error(10 Weeks postoperative)
- Uncorrected monocular visual acuity(10 Weeks postoperative)
- Manifest refraction(10 Weeks postoperative)
- Mean absolute prediction error(10 Weeks postoperative)
研究者
研究点 (1)
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