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Vivity Study in Taiwan

A Prospective Study of Vivity & Vivity Toric IOL in Taiwan: Results and Analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06719882
Enrollment
100
Registered
2024-12-06
Start date
2022-12-15
Completion date
2024-12-31
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Intraocular lens, Extended depth of focus

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.

Interventions

None listed

Sponsors

Taipei Nobel Eye Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity (LogMAR)From enrollment to the end of treatment at 3 monthsUncorrected binocular far, intermediate and near visual acuity. Corrected binocular far, intermediate and near visual acuity.

Other

MeasureTime frameDescription
Intermediate reading speed (seconds)From enrollment to the end of treatment at 3 monthsThe intermediate reading speed was measured by IReST - International Reading Speed Texts Chinese Edition

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026