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

NCT03803852 — Not applicable, Recruiting, 750 participants, Medical University of Vienna

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03803852
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment750 (Estimated)
SponsorMedical University of Vienna (Other)
ConditionsAge Related Cataracts, Astigmatism
InterventionsIntraocular Lens Implantation (Device)
Datesstart 2019-01-21, primary completion 2027-10-01 (estimated), completion 2028-01-01 (estimated), first posted 2019-01-15, last updated 2025-05-14
Locations1 site in Austria

Related Papers Related Patents Related Grants Related Experts
All trials for Age Related Cataracts All trials for Astigmatism All trials of Intraocular Lens Implantation

-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, RayOne EMV toric and PODEYE Toric group, patients receive a toric IOL according to their preoperative astigmatism

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
0°ExperimentalDevice: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
45°ExperimentalDevice: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
90°ExperimentalDevice: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
135°ExperimentalDevice: Intraocular Lens ImplantationImplantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°
  • Intraocular Lens Implantation (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

+Outcome measures

Primary outcomes

  • Change of axial intraocular lens position [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°)

Secondary outcomes

  • Decentration [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"
  • Tilt [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"
  • Anterior chamber depth [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
  • Best corrected visual acuity (BCVA) [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)
  • UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups [7 months]: Uncorrected Intermediate Visual Acuity mono or bilateral

+Eligibility

Sex: All, ages: 45 Years to 95 Years

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

+Locations (1)

FacilityCityCountryStatus
Medical University of Vienna Allgemeines KrankenhausVienna, State of ViennaAustriaRecruiting

+Publications

  • Results publication: 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
  • Results publication: 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

+Investigators