Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID06264830

Comparing Depth of Focus Effects in Cataract Surgery for High Myopic Patients Using the NGENUITY 3D Visualization System Versus Traditional Optical Microscope

Led by National Taiwan University Hospital · Updated on 2025-07-02

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

A

Alcon Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare surgical outcomes and parameters between cataract surgeries performed using a new 3D imaging system called the NGENUITY4 3D Visualization System and the current standard binocular microscope in patients with high myopia. The study focuses on how differences in depth of field between these two systems affect factors during surgery and the results, including potential complications. Participants will have high myopia and significant cataracts requiring surgery. Participants will be randomly assigned to one of two groups: one group will undergo cataract surgery using the standard binocular microscope, while the other group will have surgery using the Alcon NGENUITY4 3D Visualization System. During surgery with the NGENUITY system, the surgeon wears 3D glasses and views the operation on a 3D screen. Both groups receive standard cataract extraction with phacoemulsification and intraocular lens implantation. Throughout the surgery, researchers will measure how often and how far the microscope focus is adjusted, the distance needed to focus from the corneal surface to the lens capsule, total operation time, and ultrasound energy used. After surgery, participants will be followed for three months to monitor vision, eye pressure, and any complications. These assessments will occur on day 1, week 1, month 1, and month 3 after surgery to evaluate safety and effectiveness of the two visualization methods.

CONDITIONS

Brief Title

3D Visualization System in Highly Myopic Cataract Operation

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • High myopia with axial length of 26 millimeters or more
  • Clinically significant age-related nuclear cataract requiring surgery, with LOC III NC/NO grade 3-5
  • Participants aged 20 years or older
Not Eligible

You will not qualify if you...

  • Eye to be operated on has undergone vitrectomy surgery
  • Eye to be operated on has undergone corneal refractive surgery
  • Presence of corneal diseases affecting surgery clarity, such as dystrophy, trauma, scarring, ulcers, or softening
  • Complicated cataracts with extreme hardness, zonular laxity, lens dislocation, extensive capsular fibrosis, or LOC III NO/NC6 or C4-C5 or P4-P5 classification
  • Other non-myopia-related eye diseases significantly affecting surgery complexity, such as adhesive uveitis, corneal damage from trauma, intraocular inflammation adhesions, or severe uncorrected strabismus

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery plus immediate recovery period

Participants undergo cataract surgery using either the conventional binocular microscope or the Alcon NGENUITY® 3D Visualization System, followed by immediate post-operative care to monitor surgical outcomes and any complications.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 3 months

Participants attend follow-up visits to assess visual acuity, intraocular pressure, and monitor for any post-operative complications over three months after surgery.

4 visits at postoperative day 1, week 1, month 1, and month 3 (in-person)

Trial Site Locations

Total: 1 location

1

Department of Ophthalmology, National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

C

Cheng-Yung Lee, M.D.

T

Tzyy-Chang Ho, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Heads-up Cataract Surgery: Complication Rates, Surgical Duration, and Comparison With Traditional Microscopes.

Robert J Weinstock, Vasilios F Diakonis, Adam J Schwartz...

https://pubmed.ncbi.nlm.nih.gov/31059581

The Malaysian cataract surgery registry: incidence and risk factors of postoperative infectious endophthalmitis over a 7-year period.

Yong Zheng Wai, Lee Min Fiona Chew, Aziz Salowi Mohamad...

https://pubmed.ncbi.nlm.nih.gov/30364221

Magnification and Refocusing Comparison in Cataract Surgery Using a Heads-Up Three-Dimensional Visualization System versus Conventional Binocular Microscopy.

Mariana Ramírez Mejía, Leticia Arroyo Muñoz, Ana Beatriz Medina Perez...

https://pubmed.ncbi.nlm.nih.gov/37600146