NCT06264830

3D Visualization System in Highly Myopic Cataract Operation

Comparing the Effect of Depth of Focus Difference in High Myopic Patients Receiving Cataract Operations Between 3D Visualization System and Traditional Optical Microscope.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes.

Detailed description

The objective of this study is to compare the surgical outcomes and parameters between cataract surgeries performed using the NGENUITY® 3D Visualization System (Alcon, TX, USA), a 3D imaging system, and the current standard binocular microscope in highly myopic patients. The focus is on evaluating the differences in depth of field and their impact on intraoperative parameters and outcomes. This prospective randomized controlled trial aims to enroll patients with both high myopia and cataracts requiring surgical intervention. Participants will be randomly assigned to undergo cataract surgery using the current standard binocular microscope (control group) or the NGENUITY® 3D Visualization System (Alcon, TX, USA) (study group). The study will compare intraoperative parameters, surgical outcomes, and the incidence of potential complications, including the frequency of microscope adjustments during surgery, total distance of adjustments during surgery, distance needed to achieve clear focus from the corneal surface to the posterior capsule, surgical duration, cumulative ultrasound energy during surgery, and occurrence of surgical complications.

Conditions

• Cataract
• High Myopia

Interventions

Type	Name	Description
DEVICE	Alcon-NGENUITY®(NG)-system	During operation, the Alcon NGENUITY® (NG) System is mounted on microscope, while the surgeon will wear 3D glasses, watch 3D screen, and perform operation
PROCEDURE	Standard cataract operation	Standard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation.

Timeline

• Start date: 2024-07-03
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-02-20
• Last updated: 2025-07-02

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study