Clinical trial NCT06719882: Vivity Study in Taiwan
Official title: A Prospective Study of Vivity & Vivity Toric IOL in Taiwan: Results and Analysis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cataract
Keywords: Intraocular lens
Extended depth of focus
Lead sponsor: Taipei Nobel Eye Clinic
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who intended for sequential bilateral cataract surgery and implanted with Vivity/Vivity IOL would be asked to include in this study.

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.

Eligibility 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

Primary outcomes:
measure: Visual acuity (LogMAR)
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
Other outcomes:
measure: Intermediate reading speed (seconds)
timeFrame: From enrollment to the end of treatment at 3 months
Locations:
city: Taipei
country: Taiwan
facility: Taiwan Nobel Eye Clinic
Study officials:
affiliation: Taiwan Nobel Eye Clinic
name: ChaoKai Chang, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Kandavel R, Colvard M, Dredge J, Bayle M, Alam T, Snyder J, Hall B. Comparative Study Between Non-Diffractive Extended Depth of Focus and Monofocal Intraocular Lenses. Clin Ophthalmol. 2023 Apr 14;17:1161-1168. doi: 10.2147/OPTH.S402069. eCollection 2023.
citation: Hovanesian JA, Jones M, Allen Q. The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence. Clin Ophthalmol. 2022 Jan 18;16:145-152. doi: 10.2147/OPTH.S347382. eCollection 2022.