3D Visualization System in Highly Myopic Cataract Operation

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Number of times of Microscopic focus adjustment, measured by counting from the video recordings [Time frame: 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]
• 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.]

Secondary outcome measures (6)

• Total operation time [Time frame: 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]
• Number of Participants with intraoperative complication [Time frame: 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]
• 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]
• 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]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Department of Ophthalmology, National Taiwan University Hospital — Taipei

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06264830 · 202307103DIPC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗