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

  • End date
    Aug 22, 2024
  • participants needed
  • sponsor
    Beaver-Visitec International, Inc.
Updated on 4 October 2022
corrected visual acuity
corneal astigmatism
ocular disease
intraocular lens implantation
bilateral cataracts


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 (study no. PHY2102)


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.

Condition Cataract, Lens Opacities, Astigmatism
Treatment IOL implantation experimental
Clinical Study IdentifierNCT04778501
SponsorBeaver-Visitec International, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes
Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs
Regular corneal astigmatism (measured by a topographer)
Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes
Capability to understand and sign an IRB approved informed consent form and privacy authorization
Clear intraocular media other than cataract
Dilated pupil size large enough to visualize IOL axis markings postoperatively
Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation
Willing and able to conform to the study requirements

Exclusion Criteria

Age of patient <50 years at the day of screening
Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatic keratometer) in both eyes
Irregular astigmatism (measured by a topographer)
Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders)
Subjects with AMD suspicious eyes as determined by OCT examination
Previous intraocular or corneal surgery
Traumatic cataract
History or presence of macular edema
Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D
Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes
Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study
Concurrent or previous (within 30 days) participation in another drug or device investigation
Clinically significant dry eye as determined by the investigator´s judgement
Ocular surface disease (clinical symptoms or keratitis)
Patients showing contraindications as listed in the current Instructions for use (IFU)
Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF)
In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued
when certain conditions are present at the time of surgery, including
zonular instability
need for iris manipulation
capsular fibrosis or other opacity; and
inability to fixate IOL in desired position. In such cases, the subject shall be
followed until the condition has stabilized
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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