Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon Toric & Hoya Vivinex Impress & Hoya Nanex

  • STATUS
    Recruiting
  • End date
    Oct 14, 2023
  • participants needed
    510
  • sponsor
    Medical University of Vienna
Updated on 27 May 2022
cataract
mydriasis
intraocular lens implantation
phacoemulsification
bilateral age-related cataract

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 group, patients receive a toric IOL according to their preoperative astigmatism

Details
Condition Age Related Cataracts, Astigmatism
Treatment Intraocular lens implantation
Clinical Study IdentifierNCT03803852
SponsorMedical University of Vienna
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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)
Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)
Astigmatism of at least 1.0 Diopters (Alcon Clareon toric group)
Pupil dilation >5.5mm (Alcon Clareon 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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