3D Visualization System in Highly Myopic Cataract Operation

NCT06264830 | Recruiting FDA Device

• 1 other identifier: 202307103DIPC
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 in cataract surgery for highly myopic patients on intraoperative parameters and outcomes.

Conditions

Cataract; High Myopia

Keywords

Cataract; High Myopia; Digital 3D System; Depth of Field

Outcome Measures

Primary Outcomes (3)

• Number of times of Microscopic focus adjustment, measured by counting from the video recordings

  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

  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

  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 Outcomes (6)

• Total operation time

  Throughout operation

• Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion)

  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)

  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

  Within three month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3

Study Arms (2)

Conventional-binocular-microscope-assisted standard cataract operation

ACTIVE COMPARATOR

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

Procedure: Standard cataract operation

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

EXPERIMENTAL

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

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

Interventions

Alcon-NGENUITY®(NG)-system DEVICE

During operation, the Alcon NGENUITY® (NG) System is mounted on microscope, while the surgeon will wear 3D glasses, watch 3D screen, and perform operation

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

Standard cataract operation PROCEDURE

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

Alcon-NGENUITY® (NG)-System-assisted standard cataract operation; Conventional-binocular-microscope-assisted standard cataract operation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Alcon Research: collaborator

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (10)

• Hamasaki I, Shibata K, Shimizu T, Kono R, Morizane Y, Shiraga F. Lights-out Surgery for Strabismus Using a Heads-Up 3D Vision System. Acta Med Okayama. 2019 Jun;73(3):229-233. doi: 10.18926/AMO/56865.

  PMID: 31235970 BACKGROUND

• Weinstock RJ, Diakonis VF, Schwartz AJ, Weinstock AJ. Heads-up Cataract Surgery: Complication Rates, Surgical Duration, and Comparison With Traditional Microscopes. J Refract Surg. 2019 May 1;35(5):318-322. doi: 10.3928/1081597X-20190410-02.

  PMID: 31059581 BACKGROUND

• Kita M, Mori Y, Hama S. Hybrid wide-angle viewing-endoscopic vitrectomy using a 3D visualization system. Clin Ophthalmol. 2018 Feb 12;12:313-317. doi: 10.2147/OPTH.S156497. eCollection 2018.

  PMID: 29491704 BACKGROUND

• Skinner CC, Riemann CD. "HEADS UP" DIGITALLY ASSISTED SURGICAL VIEWING FOR RETINAL DETACHMENT REPAIR IN A PATIENT WITH SEVERE KYPHOSIS. Retin Cases Brief Rep. 2018 Summer;12(3):257-259. doi: 10.1097/ICB.0000000000000486.

  PMID: 27841831 BACKGROUND

• Coppola M, La Spina C, Rabiolo A, Querques G, Bandello F. Heads-up 3D vision system for retinal detachment surgery. Int J Retina Vitreous. 2017 Nov 20;3:46. doi: 10.1186/s40942-017-0099-2. eCollection 2017.

  PMID: 29188074 BACKGROUND

• Wai YZ, Fiona Chew LM, Mohamad AS, Ang CL, Chong YY, Adnan TH, Goh PP. The Malaysian cataract surgery registry: incidence and risk factors of postoperative infectious endophthalmitis over a 7-year period. Int J Ophthalmol. 2018 Oct 18;11(10):1685-1690. doi: 10.18240/ijo.2018.10.17. eCollection 2018.

  PMID: 30364221 BACKGROUND

• Qian Z, Wang H, Fan H, Lin D, Li W. Three-dimensional digital visualization of phacoemulsification and intraocular lens implantation. Indian J Ophthalmol. 2019 Mar;67(3):341-343. doi: 10.4103/ijo.IJO_1012_18.

  PMID: 30777950 BACKGROUND

• Ramirez Mejia M, Arroyo Munoz L, Medina Perez AB, Mendoza Velasquez C, Ceja Martinez J, Camacho Ordonez A, Guerrero-Berger O. Magnification and Refocusing Comparison in Cataract Surgery Using a Heads-Up Three-Dimensional Visualization System versus Conventional Binocular Microscopy. Clin Ophthalmol. 2023 Aug 15;17:2333-2339. doi: 10.2147/OPTH.S423372. eCollection 2023.

  PMID: 37600146 BACKGROUND

• Kelkar JA, Kelkar AS, Bolisetty M. Initial experience with three-dimensional heads-up display system for cataract surgery - A comparative study. Indian J Ophthalmol. 2021 Sep;69(9):2304-2309. doi: 10.4103/ijo.IJO_231_21.

  PMID: 34427206 BACKGROUND

• Liu J, Wu D, Ren X, Li X. Clinical experience of using the NGENUITY three-dimensional surgery system in ophthalmic surgical procedures. Acta Ophthalmol. 2021 Feb;99(1):e101-e108. doi: 10.1111/aos.14518. Epub 2020 Jul 9.

  PMID: 32643263 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Tzyy-Chang Ho

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Yung Lee, M.D.

CONTACT

886-2-23123456; G05875@hch.gov.tw

Tzyy-Chang Ho, M.D.

CONTACT

886-2-23123456; hotc@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 20, 2024
• Study Start: July 3, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)