Illuminated Chopper in Cataract Surgery

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.

Inclusion criteria

• 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

Exclusion criteria

• 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