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

NCT ID: NCT03803852

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age Related Cataracts Astigmatism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study involves 5 different groups. All groups will be investigated seperately.

Alcon Clareon toric group: 130 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 130 eyes Hoya Vivinex Impress: 120 eyes Rayner RayOne EMV toric group: 120 eyes PODEYE Toric: 120 eyes
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Intraocular Lens Implantation

Intervention Type DEVICE

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

45°

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

Group Type EXPERIMENTAL

Intraocular Lens Implantation

Intervention Type DEVICE

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

90°

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

Group Type EXPERIMENTAL

Intraocular Lens Implantation

Intervention Type DEVICE

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

135°

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

Group Type EXPERIMENTAL

Intraocular Lens Implantation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rupert Menapace

Ao.Univ.Prof.Dr. Rupert Menapace

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rupert Menapace, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna Allgemeines Krankenhaus

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rupert Menapace, Prof.Dr.

Role: CONTACT

0043-1-40400 ext. - 66300

Daniel Schartmueller, Dr.

Role: CONTACT

0043-1-40400 ext. 79450

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rupert Menapace, Prof.

Role: primary

014040066300

References

Explore related publications, articles, or registry entries linked to this study.

Schartmuller D, Lisy M, Mahnert N, Schranz M, Danzinger V, Schwarzenbacher L, Pieh S, Abela-Formanek C, Leydolt C, Menapace R. Rotational stability and refractive outcomes of a new hydrophobic acrylic toric intraocular lens. Eye Vis (Lond). 2024 Jul 2;11(1):25. doi: 10.1186/s40662-024-00393-2.

Reference Type DERIVED
PMID: 38951940 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1978/2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vivinex Impress XY1-EM vs RayOne EMV
NCT06891092 RECRUITING NA
Clareon Toric vs Eyhance Toric
NCT05481125 COMPLETED NA