Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT06264830

3D Visualization System in Highly Myopic Cataract Operation

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

45

Participants Needed

1

Research Sites

78 weeks

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 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.

CONDITIONS

Official Title

3D Visualization System in Highly Myopic Cataract Operation

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. High myopia (axial length of 26 millimeters or more).
  2. Presence of clinically significant age-related nuclear cataract requiring surgery, assessed using the International Classification System for Cataract (Lens Opacities Classification System III, LOC III), with a graded score indicating nuclear cataract (LOC III NC/NO grade 3-5).
  3. Participants must be 20 years of age or older.
Not Eligible

You will not qualify if you...

  1. The target eye has undergone vitrectomy surgery.
  2. The target eye has undergone corneal refractive surgery.
  3. Presence of corneal diseases such as corneal dystrophy, corneal trauma, corneal scarring, corneal ulcers, or clinically significant corneal softening that significantly affects the clarity of cataract surgery.
  4. Complicated cataracts with features such as extreme hardness, complex composition, zonular laxity, lens dislocation, extensive capsular fibrosis, or those falling under the international cataract classification standards LOCIII NO/NC6 or C4-C5 or P4-P5.
  5. Presence of other non-myopia-related eye diseases significantly affecting the complexity of surgery, such as adhesive uveitis causing adhesions, corneal damage due to trauma or lens dislocation, structural changes and adhesions due to intraocular inflammation, or severe uncorrected strabismus affecting eye alignment.

AI-Screening

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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.

CONTACT

T

Tzyy-Chang Ho, M.D.

CONTACT

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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