RecruitingNot ApplicableNCT06264830

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.


Sponsor

National Taiwan University Hospital

Enrollment

45 participants

Start Date

Jul 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria3

  • High myopia (axial length of 26 millimeters or more).
  • 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).
  • Participants must be 20 years of age or older.

Exclusion Criteria5

  • The target eye has undergone vitrectomy surgery.
  • The target eye has undergone corneal refractive surgery.
  • 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.
  • 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.
  • 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.

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Interventions

DEVICEAlcon-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

PROCEDUREStandard cataract operation

Standard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation.


Locations(1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, Taiwan

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NCT06264830


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