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

July 1, 2025 updated by: National Taiwan University Hospital

Comparing the Effect of Depth of Focus Difference in High Myopic Patients Receiving Cataract Operations Between 3D Visualization System and Traditional Optical Microscope.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, 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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cheng-Yung Lee, M.D.
  • Phone Number: 65190 886-2-23123456
  • Email: G05875@hch.gov.tw

Study Contact Backup

  • Name: Tzyy-Chang Ho, M.D.
  • Phone Number: 65190 886-2-23123456
  • Email: hotc@ntuh.gov.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Department of Ophthalmology, National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional-binocular-microscope-assisted standard cataract operation
In this group, patients undergo standard modern cataract operation during which the surgeon use conventional binocular microscope
Procedure: Standard cataract operation
Standard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation.
Experimental: Alcon-NGENUITY® (NG)-System-assisted standard cataract operation
In this group, patients undergo standard modern cataract operation during which the surgeon use the Alcon NGENUITY® (NG) System
Procedure: Standard cataract operation
Standard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation.
Device: Alcon-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of times of Microscopic focus adjustment, measured by counting from the video recordings
Time Frame: Throughout operation
A video recorder will focus on the sliding joint between main suspension arm of microscope and its lens system. Once the surgeon change the focus, the marks on both side of the joint will change their relative positions. The times of changes will be counted from the video recording.
Throughout operation
Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope
Time Frame: Throughout operation
On the microscope one ruler will place on the suspension arm of microscope just beside the sliding joint of main optic lens system. On the side of main optic lens system, there will be a mark. When the surgeon change the focus of microscope. The mark will change its position relative to the ruler with millimeter in scale. The total moving distance is the add-ups of all changes during operation in absolute value.
Throughout operation
Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope
Time Frame: During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted.
On the microscope one ruler will place on the suspension arm of microscope just beside the sliding joint of main optic lens system. On the side of main optic lens system, there will be a mark. When the surgeon change the focus of the microscope. The mark will change its position relative to the ruler with millimeter in scale. Distance in millimeter of subjective focus between corneal surface and surface of posterior capsule can thus be measured.
During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total operation time
Time Frame: Throughout operation
Total operation time
Throughout operation
Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion)
Time Frame: Throughout operation
Cumulative dissipated energy (CDE) is defined as mean phaco power times phaco time. CDE will be automatically measured and calculated by the Alcon centurion phacoemulsification machine, and will be demonstrated on the screen of the machine. CDE is itself the unit. The lower the CDE for an operation, the better.
Throughout operation
Number of Participants with intraoperative complication
Time Frame: Throughout operation
Number of Participants with intraoperative complication
Throughout operation
Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment)
Time Frame: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
The best-corrected visual acuity (BCVA) measured with Snellen chart is expected to range from 20/20(1.0) to 20/400(0.05). The refraction of the eye will be carefully corrected using trial lens. The higher the Snellen-chart value, and better the vision. For worse vison. The BCVA will be documented with able to count finger at certain distance ( such as100 centimeter or 30 centimeter). For even worse one, the BCVA will be documented with able to tell hand waving or not at certain distance ( such as100 centimeter or 30 centimeter). For even worse one, the BCVA will be documented with light perception or no light perception.
Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Number of Participants with post-operative complication
Time Frame: Within three month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Number of Participants with post-operative complication
Within three month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer
Time Frame: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
The intraocular pressure will be measured with pneumatic tonometer
Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Tzyy-Chang Ho, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202307103DIPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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