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

Last updated: October 16, 2023
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Astigmatism

Eye Disorders/infections

Vision Loss

Treatment

Intraocular Lens Implantation

Clinical Study ID

NCT03803852
1978/2018
  • Ages 45-95
  • All Genders

Study 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 and RayOne EMV toric groups, patients receive a toric IOL according to their preoperative astigmatism

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Uni- or bilateral age-related cataract necessitating phacoemulsification extractionand 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 toricgroup)
  • Need for spherical IOL correction between +10.00 and +25.00 D (Rayner RayOne EMV toricgroup)
  • 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 toricgroups)
  • Pupil dilation >5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group)

Exclusion

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

Study Design

Total Participants: 630
Treatment Group(s): 1
Primary Treatment: Intraocular Lens Implantation
Phase:
Study Start date:
January 21, 2019
Estimated Completion Date:
October 14, 2024

Connect with a study center

  • Medical University of Vienna Allgemeines Krankenhaus

    Vienna, 1090
    Austria

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.