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

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

Study Overview

• Status: Recruiting
• Conditions: Astigmatism; Age Related Cataracts
• Intervention / Treatment: Device: Intraocular Lens Implantation

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rupert Menapace, Prof.Dr.; Phone Number: - 66300 0043-1-40400; Email: rupert.menapace@meduniwien.ac.at
• Study Contact Backup: Name: Daniel Schartmueller, Dr.; Phone Number: 79450 0043-1-40400; Email: daniel.schartmueller@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna Allgemeines Krankenhaus
    • Contact: Rupert Menapace, Prof.; Phone Number: 014040066300; Email: rupert.menapace@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0°; Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°	Device: Intraocular Lens Implantation; 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 on the axis according to the steep meridian of the cornea
Experimental: 45°; Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°	Device: Intraocular Lens Implantation; 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 on the axis according to the steep meridian of the cornea
Experimental: 90°; Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°	Device: Intraocular Lens Implantation; 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 on the axis according to the steep meridian of the cornea
Experimental: 135°; Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°	Device: Intraocular Lens Implantation; 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 on the axis according to the steep meridian of the cornea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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°)	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 months
Decentration	Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"	7 months
Tilt	Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"	7 months
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 will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter	1 month
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups	Uncorrected Intermediate Visual Acuity mono or bilateral	7 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Rupert Menapace, Prof.Dr., Medical University Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Estimated): June 14, 2024
• Study Completion (Estimated): October 14, 2024

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: 1978/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No