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Vivity Study in Taiwan

NCT ID: NCT06719882

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cataract

Keywords

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Intraocular lens Extended depth of focus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vivity/Vivity toric

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Nobel Eye Clinic

OTHER

Sponsor Role lead

Responsible Party

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Chao-Kai Chang

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ChaoKai Chang, Ph.D.

Role: STUDY_DIRECTOR

Taiwan Nobel Eye Clinic

Locations

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Taiwan Nobel Eye Clinic

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 37082300 (View on PubMed)

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.

Reference Type RESULT
PMID: 35082481 (View on PubMed)

Other Identifiers

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005

Identifier Type: -

Identifier Source: org_study_id