RecruitingNot Applicable

3D Visualization System in Highly Myopic Cataract Operation

Taiwan45 participantsStarted 2024-07-03

Plain-language 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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of times of Microscopic focus adjustment, measured by counting from the video recordings

Timeframe: Throughout operation

Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope

Timeframe: Throughout operation

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.

Trial details

NCT IDNCT06264830

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Cheng-Yung Lee, M.D.

886-2-23123456 G05875@hch.gov.tw

View on ClinicalTrials.gov More Cataract trials

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of times of Microscopic focus adjustment, measured by counting from the video recordings

Timeframe: Throughout operation

Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope

Timeframe: Throughout operation

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.