Prospective Randomized, Paired-Eye, Comparative Study Between Cataract Surgeries With and Without an Illuminated Chopper
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Operation Time
研究概览
简要总结
This study compares cataract surgery performed with an illuminated chopper and intracameral illumination with cataract surgery performed under conventional external coaxial microscope illumination. Participants undergoing bilateral cataract surgery will have one eye treated with the illuminated chopper and the other eye treated without the illuminated chopper, with the order randomized between eyes.
The study will evaluate differences in operation time, pupil size, the need for additional intraocular medications or devices, intraoperative and postoperative complications, and postoperative clinical outcomes including visual acuity and intraocular pressure.
详细描述
This is a prospective, randomized, paired-eye comparative clinical study in participants undergoing bilateral cataract surgery. Each participant will undergo cataract surgery in both eyes. One eye will be treated using the iChopper illumination chopper with the iVision light source, while the fellow eye will undergo cataract surgery using conventional external coaxial microscope illumination. The order of the surgical method between the right and left eyes will be randomized.
The illuminated chopper provides intracameral illumination during cataract surgery and is designed to improve visualization of intraocular structures while also functioning as a lens chopper. The investigational device has received U.S. FDA 510(k) clearance.
The study will assess intraoperative outcomes including operation time, pupil size, ultrasound usage time, pupil-related surgical difficulties, intraoperative complications, and the use of additional intraocular medications or devices. Postoperative assessments will include visual acuity, manifest refraction, intraocular pressure, and postoperative complications.
Participants will undergo bilateral cataract surgery with the two procedures scheduled approximately 1 to 3 weeks apart. Follow-up assessments will be performed approximately 1 day and 30 days after surgery for each eye.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Diagnosis of bilateral cataract
- •Both eyes suitable for cataract surgery
- •Expected postoperative best-corrected visual acuity of 0.2 Snellen or better
- •No other secondary ocular surgeries planned during the study period
- •Ability to comply with all study procedures and follow-up visits
- •Ability and willingness to provide written informed consent
排除标准
- •Preoperative ocular or systemic conditions, or medication use, that may affect study outcomes, increase risk to the participant, or predispose to complications, including infectious disease, ocular atrophy, or zonular weakness
- •Poorly controlled diabetes mellitus
- •Use of alpha-blockers such as tamsulosin for benign prostatic hyperplasia
- •Planned femtosecond laser-assisted cataract surgery
- •Congenital ocular disorders
- •History of ophthalmic surgery in either eye that may affect study outcomes or increase risk, including retinal surgery, glaucoma surgery, or anterior segment surgery
- •Inability to provide informed consent
- •Pregnancy
研究组 & 干预措施
Illuminated Chopper in Right Eye
Participants assigned to this arm undergo cataract surgery using the illuminated chopper in the right eye and cataract surgery under conventional external coaxial microscope illumination in the left eye.
干预措施: iChopper Illumination Chopper and iVision Light Source (Device)
Illuminated Chopper in Right Eye
Participants assigned to this arm undergo cataract surgery using the illuminated chopper in the right eye and cataract surgery under conventional external coaxial microscope illumination in the left eye.
干预措施: Conventional Microscope Illumination (Procedure)
Illuminated Chopper in Left Eye
Participants assigned to this arm undergo cataract surgery under conventional external coaxial microscope illumination in the right eye and cataract surgery using the illuminated chopper in the left eye.
干预措施: iChopper Illumination Chopper and iVision Light Source (Device)
Illuminated Chopper in Left Eye
Participants assigned to this arm undergo cataract surgery under conventional external coaxial microscope illumination in the right eye and cataract surgery using the illuminated chopper in the left eye.
干预措施: Conventional Microscope Illumination (Procedure)
结局指标
主要结局
Operation Time
时间窗: During cataract surgery
Operation time during cataract surgery will be recorded and compared between eyes undergoing surgery with the illuminated chopper and eyes undergoing surgery with conventional microscope illumination.
Pupil Size During Cataract Surgery
时间窗: During cataract surgery
Pupil size during cataract surgery will be assessed and compared between the illuminated chopper and conventional microscope illumination conditions.
Use of Additional Intraocular Medications
时间窗: During cataract surgery
The use of additional intraocular medications during cataract surgery will be recorded and compared between the illuminated chopper and conventional microscope illumination conditions.
Use of Additional Intraocular Devices
时间窗: During cataract surgery
The use of additional intraocular devices during cataract surgery will be recorded and compared between the illuminated chopper and conventional microscope illumination conditions.
次要结局
- Intraoperative Complications(During cataract surgery)
- Postoperative Complications(From surgery through approximately 30 days after surgery)
- Postoperative Distance Visual Acuity(Day 1 and Day 30 after surgery)
- Postoperative Intraocular Pressure(Day 1 and Day 30 after surgery)