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
Qualifiers
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
Treatments tested in this trial
- Alcon-NGENUITY®(NG)-system
- Standard cataract operation
Treatment groups
45 Participants
are divided into 2 treatment groupsSponsors and collaborators
National Taiwan University Hospital
Lead sponsor
Alcon Research
Collaborator
Source ClinicalTrials.gov