A Prospective, Multicenter, Randomized Evaluation of Refractive Predictability in Patients With or Without Corneal Astigmatism (Maximum Allowable up to 1.25D) When Using the Cataract Refractive Suite and Standard Manual Techniques
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
研究概览
简要总结
The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with bilateral cataracts;
- •Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes;
- •Clear intraocular media, other than cataract, in study eye(s);
- •Willing and able to complete all required postoperative visits;
- •Able to comprehend and sign a statement of informed consent;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Significant irregular corneal astigmatism;
- •History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease;
- •Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment;
- •Any inflammation or edema (swelling) of the cornea;
- •Pregnant;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
CRS
First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery.
干预措施: Cataract Refractive Suite (CRS) (Device)
CRS
First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery.
干预措施: Standard manual technique (Procedure)
Manual
First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery.
干预措施: Cataract Refractive Suite (CRS) (Device)
Manual
First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery.
干预措施: Standard manual technique (Procedure)
结局指标
主要结局
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
时间窗: Day 20-40 from second implantation
Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
次要结局
- Estimated Aspiration Fluid Used During Surgery(Day 0 (operative day), each eye)
- Cumulative Dissipated Energy (CDE)(Day 0 (operative day), each eye)
- Phaco Aspiration Time Spent During Surgery(Day 0 (operative day), each eye)