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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
During operation, the Alcon NGENUITY® (NG) System is mounted on microscope, while the surgeon will wear 3D glasses, watch 3D screen, and perform operation
Standard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation.
Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGNumber 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.
Time frame: 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.
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
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.
Time frame: During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted.
Total operation time
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Throughout operation
Number of Participants with intraoperative complication
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)
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.
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
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
The intraocular pressure will be 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