Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
Recruiting now · Not applicable
Conditions studied: Age Related Cataracts, Astigmatism
In brief
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
Key facts
- Study ID
- NCT03803852
- Run by
- Medical University of Vienna
- People needed
- 750
- Starts
- 2019-01-21
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2025-05-14
Who can join
Age: 45 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Medical University of Vienna Allgemeines Krankenhaus — Vienna, State of Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
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