NCT03803852

Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 45 Years – 95 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-01-21
• Primary completion: 2027-10-01
• Completion: 2028-01-01
• First posted: 2019-01-15
• Last updated: 2025-05-14

Locations

1 site across 1 country: Austria