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Clinical Investigation of a Monofocal Toric Intra Ocular Lens (IOL) in Cataractous Eyes

NCT05255029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-07-19

No results posted yet for this study

Summary

This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery be implanted with a hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (model POD T 49P).

Conditions

  • Cataract
  • Lens Opacities
  • Astigmatism

Interventions

DEVICE

POD T 49P implantation experimental

The investigational lens will be implanted within the capsular bag after removal of the natural crystalline lens following phacoemulsification and alignment the toric axis of investigational lens to the intend axis which was calculated by the Toric calculator software. When enroll the test lenses into both eyes, the lens is implanted first to the eye with more advanced cataract. If both eyes have a similar degree of cataract, perform the surgery first for the right eye. The timing of surgery the investigational lens into the fellow eye will be determined after the investigator and the investigator (hereinafter referred to as the investigator) have confirmed the safety of the previously operated eye.

Sponsors & Collaborators

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Principal Investigators

  • MIYATA Kazunori, MD · Miyata Eye 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
2021-12-24
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Japan

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 NCT05255029 on ClinicalTrials.gov