Evaluation of different intraocular lenses for cataract surgery
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
This study is testing different types of lenses used in cataract surgery to see which one helps people with astigmatism see better after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 45 Years to 95 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT03803852 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of various hydrophobic acrylic intraocular lenses (IOLs) in patients undergoing cataract surgery. Participants with age-related cataracts and astigmatism will receive one of three types of toric IOLs, and their postoperative outcomes will be assessed through visual acuity and lens rotation evaluations at multiple time points. The study aims to determine the optimal lens type for improving vision in patients with specific astigmatism levels. All procedures will be conducted following informed consent from the participants.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 95 with uni- or bilateral age-related cataracts requiring surgery and specific astigmatism levels.
Not a fit: Patients with a history of ocular surgery, uncontrolled glaucoma, or other significant ocular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved visual outcomes for patients undergoing cataract surgery with astigmatism.
How similar studies have performed: Previous studies have shown positive outcomes with similar approaches using toric IOLs for astigmatism correction in cataract surgery.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna Allgemeines Krankenhaus — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Rupert Menapace, Prof.Dr. — Medical University Vienna
- Study coordinator: Rupert Menapace, Prof.Dr.
- Email: rupert.menapace@meduniwien.ac.at
- Phone: 0043-1-40400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.