Comparison of different intraocular lenses for cataract surgery
Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses
This study is testing how well different types of lenses used in cataract surgery can improve vision for people getting their cataracts removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 461 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05822089 on ClinicalTrials.gov |
What this trial studies
This study involves the implantation of approved intraocular lenses (IOLs) in patients undergoing cataract surgery due to age-related cataracts. Participants will receive bilateral randomized IOLs after phacoemulsification, and their postoperative outcomes will be monitored according to an approved investigational plan. The goal is to evaluate the effectiveness of different IOLs in improving visual outcomes for patients. Informed consent will be obtained from all participants prior to the procedure.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 100 with bilateral age-related cataracts and a visual potential of 20/25 or better.
Not a fit: Patients with a history of intraocular surgery, significant ocular diseases, or those with uncontrolled systemic conditions 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.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating different IOLs, indicating that this methodology is not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation * Age 50 to 100 * Visual potential in both eyes of 20/25 or better as determined by investigators estimation * Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL) * postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X)) * Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X)) Exclusion Criteria: * Preceding intraocular surgery or ocular trauma * Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma) * Pupil diameter \< 2.0 mm (photopic) * Laser treatment * Uncontrolled systemic or ocular disease * Pregnancy/Nursing * childbearing ability
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Christina Leydolt, MD — Medical University of Vienna
- Study coordinator: Christina Leydolt, MD
- Email: christina.leydolt@meduniwien.ac.at
- Phone: +43 (01) 40 400 79480
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.