RecruitingNot Applicable

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

Austria750 participantsStarted 2019-01-21

Plain-language 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

Who can participate

Age range45 Years – 95 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change of axial intraocular lens position

Timeframe: 7 months

Trial details

NCT IDNCT03803852

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Rupert Menapace, Prof.Dr.

0043-1-40400 rupert.menapace@meduniwien.ac.at