Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal… (NCT04005651) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL
France, Germany, Spain100 participantsStarted 2019-05-30
Plain-language 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.
Who can participate
Age range45 Years
SexALL
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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 t…