Vivity Study in Taiwan

NCT06719882 | Active Not Recruiting

• 1 other identifier: 005
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Keywords

Intraocular lens; Extended depth of focus

Outcome Measures

Primary Outcomes (1)

• Visual acuity (LogMAR)

  Uncorrected binocular far, intermediate and near visual acuity. Corrected binocular far, intermediate and near visual acuity.

  From enrollment to the end of treatment at 3 months

Other Outcomes (1)

• Intermediate reading speed (seconds)

  From enrollment to the end of treatment at 3 months

Study Arms (1)

Vivity/Vivity toric

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Nobel Eye Clinic: lead

Study Sites (1)

Taiwan Nobel Eye Clinic

Taipei, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 37082300 RESULT

• 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.

  PMID: 35082481 RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• ChaoKai Chang, Ph.D.

  Taiwan Nobel Eye Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: December 6, 2024
• Study Start: December 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)