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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 95
Healthy Volunteers: f
View:

• Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation

• Age: 45 to 95

• Need for spherical IOL correction between 10.00 and 30.00 D

• Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric group)

• Need for spherical IOL correction between +10.00 and +25.00 D (Rayner RayOne EMV toric group)

• Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)

• Astigmatism of at least 1.0 Diopters (Alcon Clareon toric and Rayner RayOne EMV toric groups and PODEYE Toric)

• Pupil dilation \>5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group)

Locations
Other Locations
Austria
Medical University of Vienna Allgemeines Krankenhaus
RECRUITING
Vienna
Contact Information
Primary
Rupert Menapace, Prof.Dr.
rupert.menapace@meduniwien.ac.at
0043-1-40400
Backup
Daniel Schartmueller, Dr.
daniel.schartmueller@meduniwien.ac.at
0043-1-40400
Time Frame
Start Date: 2019-01-21
Estimated Completion Date: 2028-01
Participants
Target number of participants: 750
Treatments
Experimental:
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
Experimental: 45°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
Experimental: 90°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
Experimental: 135°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov