Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL
Aphakia, Postcataract, Cataract; Eye Disease
About this trial
This is an interventional treatment trial for Aphakia, Postcataract
Eligibility Criteria
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)
Sites / Locations
- OphtALLIANCE Clinique Jules Verne
- Augenklinik Ahaus
- Internationale Innovative Ophthalmochirgie
- Augentagesklinik Rheine
- IOA Madrid Innova Ocular
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
POD L GF
Symfony®
AcrySof®
Approximately 50 subjects who are scheduled for multifocal IOL implantation and enrolled in the study will be randomized into the POD L GF arm. Subjects will be implanted bilaterally with the European Conformity (CE) marked POD L GF trifocal IOL and assessed according to the study visit schedule.
Approximately 50 subjects who are scheduled for multifocal IOL implantation and enrolled in the study will be randomized into the Symfony arm. Subjects will be implanted bilaterally with the CE marked TECNIS Symfony® IOL and assessed according to the study visit schedule.
Approximately 50 subjects who are scheduled for monofocal IOL implantation and enrolled in the study will be placed in the AcrySof® arm. Subjects will be implanted bilaterally with the CE marked AcrySof® IQ monofocal IOL and assessed according to the study visit schedule.