NCT03803852 Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
| NCT ID | NCT03803852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Age Related Cataracts |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2019-01-21 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2019-01-21 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Rupert Menapace, Prof.Dr.
PRINCIPAL INVESTIGATOR
Medical University Vienna
Frequently Asked Questions
Who can join the NCT03803852 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 95 Years, studying Age Related Cataracts. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03803852 currently recruiting?
Yes, NCT03803852 is actively recruiting participants. Contact the research team at rupert.menapace@meduniwien.ac.at for enrollment information.
Where is the NCT03803852 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT03803852 clinical trial?
NCT03803852 is sponsored by Medical University of Vienna. The principal investigator is Rupert Menapace, Prof.Dr. at Medical University Vienna. The trial plans to enroll 750 participants.