Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 100
Healthy Volunteers: f
View:
• Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
• Age 50 to 100
• Visual potential in both eyes of 20/25 or better as determined by investigators estimation
• Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
• Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)
Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Christina Leydolt, MD
christina.leydolt@meduniwien.ac.at
+43 (01) 40 400 79480
Time Frame
Start Date: 2021-12-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 311
Treatments
Experimental: Monofocal IOL I vs. enhanced monofocal IOL I
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
Experimental: Monofocal IOL II vs. enhanced monofocal IOL I
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)
Experimental: Monofocal IOL III vs. enhanced monofocal IOL II
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).
Experimental: Enhanced monofocal IOL II vs. enhanced monofocal IOL II
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target
Experimental: Monofocal IOL IV vs. enhanced monofocal IOL III
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)
Experimental: Extended depth of focus IOL IV in eyes with low to moderate irregular astigmatism
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm six (VI) participants will receive an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed.
Experimental: Extended Depth of Focus IOL in eyes with irregular astigmatism
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm seven (VII) participants will receive an extended depth of focus IOL (IC-8 Apthera IOL) in one eye if irregular astigmatism is observed.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna