Using a 3D imaging system for cataract surgery in patients with high myopia
Comparing the Effect of Depth of Focus Difference in High Myopic Patients Receiving Cataract Operations Between 3D Visualization System and Traditional Optical Microscope.
This study tests if using a 3D imaging system during cataract surgery helps people with high myopia have better outcomes compared to the traditional microscope.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06264830 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the NGENUITY® 3D Visualization System compared to traditional binocular microscopes during cataract surgery for patients with high myopia. It aims to evaluate how differences in depth of field affect surgical outcomes and intraoperative parameters. Participants will be randomly assigned to either the 3D system or the standard microscope, and various metrics such as surgical duration, adjustments needed, and complication rates will be compared. The goal is to determine if the 3D system provides significant advantages in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 or older with high myopia (axial length of 26 mm or more) and clinically significant cataracts requiring surgery.
Not a fit: Patients who have undergone previous vitrectomy or corneal refractive surgery, or those with complicated cataracts or significant corneal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical precision and outcomes for patients with high myopia undergoing cataract surgery.
How similar studies have performed: While the use of 3D visualization systems in surgery is gaining traction, this specific application in highly myopic cataract surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei
- Department of Ophthalmology, National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Tzyy-Chang Ho — National Taiwan University Hospital
- Study coordinator: Cheng-Yung Lee, M.D.
- Email: G05875@hch.gov.tw
- Phone: 886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.