3D Visualization System in Highly Myopic Cataract Operation (3D-HiMCO)

National Taiwan University

Status: Enrolling

Conditions: Cataract; High Myopia

Treatments: Device: Alcon-NGENUITY®(NG)-system; Procedure: Standard cataract operation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06264830

202307103DIPC

Details and patient eligibility

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Conventional-binocular-microscope-assisted standard cataract operation

Active Comparator group

Description:

In this group, patients undergo standard modern cataract operation during which the surgeon use conventional binocular microscope

Treatment:

Procedure: Standard cataract operation

Alcon-NGENUITY® (NG)-System-assisted standard cataract operation

Experimental group

Description:

In this group, patients undergo standard modern cataract operation during which the surgeon use the Alcon NGENUITY® (NG) System

Treatment:

Procedure: Standard cataract operation

Device: Alcon-NGENUITY®(NG)-system