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PMCF Study of Preloaded Trifocal IOL

NCT04884178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-04-19

No results posted yet for this study

Summary

This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.

Conditions

  • Cataract

Interventions

DEVICE

Trifocal Preloaded IOL Delivery System

UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan.

Sponsors & Collaborators

  • AST Products, Inc.

    collaborator INDUSTRY

  • ICARES Medicus, Inc.

    lead INDUSTRY

Principal Investigators

  • Yih-Shiou Hwang, Dr. · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2022-04-18
Completion
2023-08-22

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884178 on ClinicalTrials.gov