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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
750 participants
INTERVENTIONAL
2019-01-21
2028-01-31
Brief Summary
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In the Alcon Clareon toric, RayOne EMV toric and PODEYE Toric group, patients receive a toric IOL according to their preoperative astigmatism
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
NONE
Study Groups
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0°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
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
45°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
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
90°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
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
135°
Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
95 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Rupert Menapace
Ao.Univ.Prof.Dr. Rupert Menapace
Principal Investigators
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Rupert Menapace, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University Vienna
Locations
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Medical University of Vienna Allgemeines Krankenhaus
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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1978/2018
Identifier Type: -
Identifier Source: org_study_id
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