PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia

Status Active, not recruiting

Clinical Trial Summary

Clinical Trial Description

This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE. The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens. In total approx. 23 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days. Subjects participating in the trial will attend a total of maximum 12 study visits over a period of 630-780 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, 330-420 days and 630-780 days postoperative visits). Subjects would have the option for unscheduled visits if required medically. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04778501
Study type	Interventional
Source	Beaver-Visitec International, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 7, 2021
Completion date	August 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia — PHY2102

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms