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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-95
SponsorMedical University of Vienna

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Preceding ocular surgery or trauma

Recurrent intraocular inflammation of unknown etiology

Uncontrolled glaucoma

Uncontrolled systemic or ocular disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraocular Lens Implantation

    Device

    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

Treatment groups

750 Participants
are divided into 4 treatment groups
Group A: 0°Experimental treatment 1 intervention
Group B: 45°Experimental treatment 1 intervention
Group C: 90°Experimental treatment 1 intervention
Group D: 135°Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change of axial intraocular lens position

Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)

Time frame
7 months

Secondary outcomes

1

Decentration

Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"

Time frame
7 months
2

Tilt

Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"

Time frame
7 months
3

Anterior chamber depth

The anterior chamber depth (Axial position of the IOL) of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter

Time frame
1 month
4

Best corrected visual acuity (BCVA)

BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar)

Time frame
7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.