Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL

  • STATUS
    Recruiting
  • days left to enroll
    51
  • participants needed
    150
  • sponsor
    Beaver-Visitec International, Inc.
Updated on 25 March 2022
corrected visual acuity
mydriasis
intraocular lens implantation
alcon

Summary

The objectives of the Post-Market Follow-up (PMCF) clinical investigation are to determine the safety and performance of a hydrophobic trifocal intraocular lens POD L GF in comparison with two comparator lenses: another multifocal intraocular lens (Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL); and a monofocal intraocular lens (Alcon AcrySof® IQ Monofocal IOL) through one year of post-operative assessments.

Description

This is a prospective, multicenter, randomized, active controlled comparative binocular Post Market Follow-up (PMCF) clinical study to demonstrate safety and efficacy between the trifocal intraocular lens POD L GF and the Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL and the Alcon AcrySof® IQ Monofocal IOL.

Patients who are scheduled to undergo cataract extraction in one or both eyes and posterior chamber intraocular lens implants may be screened for eligibility in the study and, if eligible, complete a pre-operative screening visit. Both eyes of subjects who are eligible to receive the POD L GF IOL or the Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL must be eligible to receive bilateral multifocal IOL implants. Both eyes of subjects who are eligible to receive the Alcon AcrySof® IQ Monofocal IOL must be eligible to receive bilateral monofocal IOL implants.

At the time of the first eye surgery, the subjects to be implanted with either the POD L GF (test) IOL or the Johnson & Johnson TECNIS Symfony® Extended Range of Vision (comparator) IOL will be randomized to receive either the test or comparator IOL in a 1:1 ratio. In addition, 50 subjects will be implanted with the Alcon AcrySof® IQ Monofocal IOL. All subjects will undergo bilateral IOL implantation and will receive the same brand of lenses in each eye. Second eye implantations will be delayed until 1 to 30 days after the first eye implantation.

Details
Condition Aphakia, Postcataract, Cataract; Eye Disease
Treatment POD L GF IOL, Symfony® IOL, AcrySof® IOL
Clinical Study IdentifierNCT04005651
SponsorBeaver-Visitec International, Inc.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female adults ages 45 or older on the day of screening who have cataract(s) in one or both eyes
Capability to understand and sign an Ethics Committee (EC) approved informed consent form and privacy authorization
Corrected visual acuity projected by potential acuity meter (PAM) testing or other potential visual acuity test procedure to be better than 20/32 after intraocular lens implantation
Clear intraocular media other than cataract
Calculated IOL power is within the range of the study IOLs
Dilated pupil size large enough to visualize IOL axis markings postoperatively
Willing and able to conform to the study requirements

Exclusion Criteria

Subjects with diagnosed degenerative visual disoerders (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 age-related macular degeneration (AMD) suspicious eyes as determined by optical coherence tomography (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
Greater than 1 diopter of pre-operative corneal astigmatism or any irregular astigmatism
Previous intraocular or corneal surgery
Traumatic cataract
History or presence of macular edema
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
Instability of keratometry or biometry measurements
Ocular hypertension or glaucoma
Significant dry eye
Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on eCRF)
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