Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
Medical University of Vienna
750 participants
Jan 21, 2019
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria8
- 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 Criteria13
- 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
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03803852