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Recruiting NCT03803852

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

No phase Interventional Age Related Cataracts Astigmatism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraocular Lens Implantation.
Who it may be relevant to
Registry conditions: Age Related Cataracts, Astigmatism. Basic parameters: 45 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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

Primary outcome measures

  • Change of axial intraocular lens position [Time frame: 7 months]
Secondary outcome measures (5)
  • Decentration [Time frame: 7 months]
  • Tilt [Time frame: 7 months]
  • Anterior chamber depth [Time frame: 1 month]
  • Best corrected visual acuity (BCVA) [Time frame: 7 months]
  • UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups [Time frame: 7 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Vienna Allgemeines Krankenhaus — Vienna

Publications

  • Lisy M, Danzinger V, Schranz M, Mahnert N, Abela-Formanek C, Leydolt C, Menapace R, Schartmuller D. Assessing postoperative toric intraocular lens rotation: comparative analysis. J Cataract Refract Surg. 2025 Mar 1;51(3):196-203. doi: 10.1097/j.jcrs.0000000000001585. PMID 39602338
  • 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. PMID 38951940

Identifiers

NCT: NCT03803852 · 1978/2018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗