Vivity Study in Taiwan

Active, not recruiting

• Conditions: Cataract

• Registration Number: NCT06719882
• Lead Sponsor: Taipei Nobel Eye Clinic

Brief Summary

The aim of study is to evaluate the quality of vision after bilateral Vivity or Vivity toric EDOF IOLs implantation in Taiwan.

Detailed Description

This study was a prospective, single arm study. The inclusion criteria for this study were the presence of cataracts in both eyes and corrected distance visual acuity (CDVA) of both eyes under 20/40, who received bilateral Vivity IOL implantation after cataract surgery, targeting emmetropia or mini-monovision of both eyes. Phacoemulsification cataract surgery was performed on all patients. The exclusion criteria were complicated cataract; corneal opacities or irregularities; severe dry eye (Schirmer's test I ≤ 5 mm); amblyopia; anisometropia; surgical complications such as posterior capsular bag rupture, vitreous loss, or IOL tilt/decentration; coexisting ocular pathologies such as glaucoma, nondilating pupil, history of intraocular surgery, refractive surgery, or retinopathy; optic nerve or macular diseases; and refusal or inability to maintain follow-up. When corneal astigmatism was more than 0.75 diopters (D), a toric IOL was implanted.

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2024-11-10
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with age-related cataract requiring surgery treatment

• Patient who received bilateral, uneventful implantation of Vivity IOLs

• Patient's IOL power is between 10-30D, and T2-T6 for toric correction

• Cataract grade 0~3 based on the Wisconsin cataract grading system

  • Exclusion criteria:

• Cataract grade 4~5 based on the Wisconsin cataract grading system

• Patient's IOL power is outside of 10-30D or T2-T6 for toric correction

• Patient with the following ocular comorbidities:

• Corneal opacities or irregularities;

• Severe dry eye;

• Amblyopia;

• Glaucoma;

• Non-dilating pupil;

• History of intraocular surgery, laser therapy, or retinopathy;

• Optic nerve or macular diseases;

• Uncontrolled diabetic mellitus or systemic immune disease;

• Refusal or unable to maintain follow-up

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity (LogMAR)	From enrollment to the end of treatment at 3 months	Uncorrected binocular far, intermediate and near visual acuity. Corrected binocular far, intermediate and near visual acuity.

Trial Locations

Locations (1)

Taiwan Nobel Eye Clinic; 🇨🇳 Taipei, Taiwan