Clinical trial NCT06264830: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
High Myopia
Keywords: Cataract
High Myopia
Digital 3D System
Depth of Field
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-02-20
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of times of Microscopic focus adjustment, measured by counting from the video recordings
timeFrame: Throughout operation
measure: Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope
timeFrame: Throughout operation
measure: Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope
timeFrame: During the operation, immediately after lens material is removed, and immediately before the intraocular lens is implanted.
Secondary outcomes:
measure: Total operation time
timeFrame: Throughout operation
measure: Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion)
timeFrame: Throughout operation
measure: Number of Participants with intraoperative complication
timeFrame: Throughout operation
measure: 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)
timeFrame: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
measure: Number of Participants with post-operative complication
timeFrame: Within three month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
measure: Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer
timeFrame: Within 3 month after operation, at postoperative day1, at postoperative week 1, at post operative month 1, at post operative month 3
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tzyy-Chang Ho
role: PRINCIPAL_INVESTIGATOR
References:
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