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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Intraocular Lens Implantation
DeviceImplantation 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
Trial outcomes
Primary outcomes
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°)
Secondary outcomes
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"
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"
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
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)
Sponsors and contacts
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