Vivity Study in Taiwan

Taipei Nobel Eye Clinic

Status: Active, not recruiting

Conditions: Cataract

Study type: Observational

Funder types: Other

Identifiers

NCT06719882

005

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 1 patient group

Vivity/Vivity toric