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

May 8, 2025 updated by: Rupert Menapace, Medical University of Vienna

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 and PODEYE 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 and PODEYE 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 and PODEYE 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 and PODEYE Toric IOL on the axis according to the steep meridian of the cornea

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of axial intraocular lens position
Time Frame: 7 months
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°)
7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity (BCVA)
Time Frame: 7 months
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
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups
Time Frame: 7 months
Uncorrected Intermediate Visual Acuity mono or bilateral
7 months
Decentration
Time Frame: 7 months
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"
7 months
Tilt
Time Frame: 7 months
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"
7 months
Anterior chamber depth
Time Frame: 1 month
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rupert Menapace, Prof.Dr., Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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