PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL (PHY2001)

  • STATUS
    Recruiting
  • End date
    Feb 29, 2024
  • participants needed
    244
  • sponsor
    Beaver-Visitec International, Inc.
Updated on 4 October 2022
astigmatism
Accepts healthy volunteers

Summary

Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.

Description

This is a multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of Enhanced Depth of Focus intraocular lenses (Isopure 1.2.3.) or monofocal lenses (Micropure 1.2.3.). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.

The study will be carried out in up to five clinical centers in Europe and Asia.

The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic EDOF intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens is the parent IOL, belonging to the same IOL family of this manufacturer. It is a hydrophobic, glistening-free, acrylic monofocal IOL (Micropure 1.2.3.). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of maximum 11 study visits (1 preoperative, 1 or 2 operative and up to 8 postoperative) over a period of 12 months. If local requirements allow, preoperative and operative visit can be done on the same day. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 120-180 days follow up visit. Secondary endpoint data will be collected at the 330-420 days follow up visit. Data interim analyses will be done after the last patient finished the 120-180 days postoperative examination to support the study publication plan.

Details
Condition Cataract, Lens Opacities
Treatment IOL implantation experimental (Isopure 1.2.3.), IOL implantation active comparator (Micropure 1.2.3.)
Clinical Study IdentifierNCT04249492
SponsorBeaver-Visitec International, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cataractous eyes with no comorbidity
Calculated IOL power is within the range of the study IOLs
Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes
Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer)
Clear intraocular media other than cataract
Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Signed informed consent

Exclusion Criteria

Age of patient < 45 years
Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
Irregular astigmatism
Difficulty for cooperation (distance from their home, general health conditions)
Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
Subjects with AMD suspicious eyes as determined by OCT examination
Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema
Previous intraocular or corneal surgery
Traumatic cataract
History or presence of macular edema
Instability of keratometry or biometry measurements
Ocular hypertension or glaucoma
Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions)
Expected complicated surgery
Significant dry eye
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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