A Prospective Study of Vivity & Vivity Toric IOL in Taiwan: Results and Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual acuity (LogMAR)
研究概览
简要总结
The aim of study is to evaluate the quality of vision after bilateral Vivity or Vivity toric EDOF IOLs implantation in Taiwan.
详细描述
This study was a prospective, single arm study. The inclusion criteria for this study were the presence of cataracts in both eyes and corrected distance visual acuity (CDVA) of both eyes under 20/40, who received bilateral Vivity IOL implantation after cataract surgery, targeting emmetropia or mini-monovision of both eyes. Phacoemulsification cataract surgery was performed on all patients. The exclusion criteria were complicated cataract; corneal opacities or irregularities; severe dry eye (Schirmer's test I ≤ 5 mm); amblyopia; anisometropia; surgical complications such as posterior capsular bag rupture, vitreous loss, or IOL tilt/decentration; coexisting ocular pathologies such as glaucoma, nondilating pupil, history of intraocular surgery, refractive surgery, or retinopathy; optic nerve or macular diseases; and refusal or inability to maintain follow-up. When corneal astigmatism was more than 0.75 diopters (D), a toric IOL was implanted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age-related cataract requiring surgery treatment
- •Patient who received bilateral, uneventful implantation of Vivity IOLs
- •Patient's IOL power is between 10-30D, and T2-T6 for toric correction
- •Cataract grade 0~3 based on the Wisconsin cataract grading system
- •Exclusion criteria:
- •Cataract grade 4~5 based on the Wisconsin cataract grading system
- •Patient's IOL power is outside of 10-30D or T2-T6 for toric correction
- •Patient with the following ocular comorbidities:
- •Corneal opacities or irregularities;
- •Severe dry eye;
- •Amblyopia;
- •Glaucoma;
- •Non-dilating pupil;
- •History of intraocular surgery, laser therapy, or retinopathy;
- •Optic nerve or macular diseases;
- •Uncontrolled diabetic mellitus or systemic immune disease;
- •Refusal or unable to maintain follow-up
排除标准
- 未提供
结局指标
主要结局
Visual acuity (LogMAR)
时间窗: From enrollment to the end of treatment at 3 months
Uncorrected binocular far, intermediate and near visual acuity. Corrected binocular far, intermediate and near visual acuity.
次要结局
未报告次要终点
研究者
Chao-Kai Chang
Doctor
Taipei Nobel Eye Clinic