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

Medical University of Vienna

Status: Enrolling

Conditions: Astigmatism; Age Related Cataracts

Treatments: Device: Intraocular Lens Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03803852

1978/2018

Details and patient eligibility

About

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

Enrollment: 750 estimated patients

Sex: All

Ages: 45 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• Preceding ocular surgery or trauma

  • Recurrent intraocular inflammation of unknown etiology
  • Uncontrolled glaucoma
  • Uncontrolled systemic or ocular disease
  • Blind fellow eye
  • Microphthalmus
  • Corneal abnormality (Corneal scaring)
  • History of uveitis/iritis
  • Iris neovascularization
  • Proliferative diabetic retinopathy
  • Pregnancy
  • Lactation
  • Females of childbearing age will be asked if pregnancy is possible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 4 patient groups

0°

Experimental group

Description:

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°

Treatment:

Device: Intraocular Lens Implantation

45°

Experimental group

Description:

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°

Treatment:

Device: Intraocular Lens Implantation

90°

Experimental group

Description:

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°

Treatment:

Device: Intraocular Lens Implantation

135°

Experimental group

Description:

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°

Treatment:

Device: Intraocular Lens Implantation