Status:
RECRUITING
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
Lead Sponsor:
Medical University of Vienna
Conditions:
Age Related Cataracts
Astigmatism
Eligibility:
All Genders
45-95 years
Phase:
NA
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 surger...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT03803852
Start Date
January 21 2019
End Date
January 1 2028
Last Update
May 14 2025
Active Locations (1)
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1
Medical University of Vienna Allgemeines Krankenhaus
Vienna, Vienna, Austria, 1090