A Prospective, Multicenter Clinical Study Comparing Outcomes of Two Trifocal Toric Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 11
- 主要终点
- Binocular distance corrected intermediate visual acuity (BCIDVA)
研究概览
简要总结
To evaluate the clinical outcomes and patient satisfaction of two commercially available trifocal toric intraocular lenses Primary Objective: To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses. Secondary Objectives: To assess and compare the safety of two trifocal toric intraocular lenses.
详细描述
Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of patient >21 Years
- •Patient diagnosed with cataract.
- •Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry
- •Calculated IOL power is within the range of investigational IOLs.
- •Patient willing to sign inform consent form.
- •Clear intraocular media other than cataract.
- •Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.
排除标准
- •Previous intraocular or corneal surgery.
- •Traumatic cataract
- •Pregnancy (as stated by patient) or lactation.
- •Concurrent participation in another drug or device investigation.
- •Irregular astigmatism.
- •Patient receiving chlorquine treatment.
- •Subjects with any systemic disease that could increase operative risk or confound the outcome.
- •Active ocular disease in the operative eye other than cataract.
- •Vulnerable subjects as defined in section 12.3.
- •Corneal Astigmatism > 4.5 D
结局指标
主要结局
Binocular distance corrected intermediate visual acuity (BCIDVA)
时间窗: 6 months
The primary effectiveness endpoint is binocular distance corrected intermediate visual acuity (BCIDVA) at 70 cms at 6 months postoperative, with a target of equivalency between the two IOLs.
次要结局
未报告次要终点