Status:

RECRUITING

3D Visualization System in Highly Myopic Cataract Operation

Lead Sponsor:

National Taiwan University Hospital

Collaborating Sponsors:

Alcon Research

Conditions:

Cataract

High Myopia

Eligibility:

All Genders

20+ years

Phase:

NA

Brief 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...

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, a...

Eligibility Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.

Key Trial Info

Start Date :

July 3 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT06264830

Start Date

July 3 2024

End Date

December 31 2025

Last Update

July 2 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Ophthalmology, National Taiwan University Hospital

Taipei, Taiwan, 100