Status:
RECRUITING
3D Visualization System in Highly Myopic Cataract Operation
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Alcon Research
Conditions:
Cataract
High Myopia
Eligibility:
All Genders
20+ years
Phase:
NA
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...
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, a...
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.
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06264830
Start Date
July 3 2024
End Date
December 31 2025
Last Update
July 2 2025
Active Locations (1)
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1
Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan, 100