Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
NCT03803852 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750
Last updated 2025-05-14
Summary
The investigational devices are approved intraocular lenses (IOL) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Within the study, three different IOLs will be investigated and separately evaluated. Cataract surgery with IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be postoperative refraction, visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month and 4-7 months.
In the Alcon Clareon toric, RayOne EMV toric and PODEYE Toric group, patients receive a toric IOL according to their preoperative astigmatism
Conditions
- Age Related Cataracts
- Astigmatism
Interventions
- DEVICE
-
Intraocular Lens Implantation
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens. Implantation of the Alcon Clareon toric and Rayner RayOne EMV toric IOL and PODEYE Toric IOL on the axis according to the steep meridian of the cornea
Sponsors & Collaborators
-
Medical University of Vienna
lead OTHER
Principal Investigators
-
Rupert Menapace, Prof.Dr. · Medical University Vienna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-21
- Primary Completion
- 2027-10-31
- Completion
- 2028-01-31
Countries
- Austria
Study Locations
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