3D Visualization System in Highly Myopic Cataract Operation

Last updated: October 3, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disease

Vision Loss

Myopia

Treatment

Alcon-NGENUITY®(NG)-system

Standard cataract operation

Clinical Study ID

NCT06264830
202307103DIPC
  • Ages > 20
  • All Genders

Study 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 Criteria

Inclusion

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 OpacitiesClassification 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

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, cornealscarring, corneal ulcers, or clinically significant corneal softening thatsignificantly 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 fallingunder the international cataract classification standards LOCIII NO/NC6 or C4-C5 orP4-P5.

  5. Presence of other non-myopia-related eye diseases significantly affecting thecomplexity of surgery, such as adhesive uveitis causing adhesions, corneal damagedue to trauma or lens dislocation, structural changes and adhesions due tointraocular inflammation, or severe uncorrected strabismus affecting eye alignment.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Alcon-NGENUITY®(NG)-system
Phase:
Study Start date:
July 03, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Department of Ophthalmology, National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

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