3D Visualization System in Highly Myopic Cataract Operation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Alcon-NGENUITY®(NG)-system
DeviceDuring operation, the Alcon NGENUITY® (NG) System is mounted on microscope, while the surgeon will wear 3D glasses, watch 3D screen, and perform operation
Standard cataract operation
Procedure/SurgeryStandard, modern cataract extraction with standard phacoemulsification technique, and posterior chamber intraocular lens implantation.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Conventional-binocular-microscope-assisted standard cataract operationActive comparator 1 intervention
Group B: Alcon-NGENUITY® (NG)-System-assisted standard cataract operationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Throughout operation2
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 operation3
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.Secondary outcomes
1
Total operation time
Total operation time
Time frame
Throughout operation2
Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion)
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 operation3
Number of Participants with intraoperative complication
Number of Participants with intraoperative complication
Time frame
Throughout operation4
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 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Alcon Research
Collaborator
Source ClinicalTrials.gov