3D Visualization System in Highly Myopic Cataract Operation

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Feb 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special 3D imaging system called the NGENUITY® 3D Visualization System during cataract surgery for patients with high myopia (very nearsightedness). The goal is to see how this new technology compares to the traditional microscope used in surgeries, especially in terms of how well the surgery goes and the results for patients. This trial is currently looking for participants, and anyone who is 20 years old or older with a specific type of cataract and high myopia (with an eye length of 26 mm or more) may be eligible to join.

If you are considering participating, you should know that certain conditions may exclude you, such as having had previous eye surgeries, specific eye diseases, or particularly complicated cataracts. Participants in the study can expect to undergo cataract surgery using the 3D system, and their experiences and outcomes will be closely monitored by the researchers. This trial is important because it could help improve surgical techniques and results for people with high myopia, leading to better vision and recovery after surgery.

Gender

ALL

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.