Comparing two types of enhanced monofocal lenses for cataract surgery
Intermediate Visual Acuity Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses
This study is testing two types of lenses used in cataract surgery to see which one helps people see better and rely less on glasses for everyday tasks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | All |
| Sponsor | Vienna Institute for Research in Ocular Surgery Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06345820 on ClinicalTrials.gov |
What this trial studies
This study compares the clinical performance of two enhanced monofocal intraocular lenses (IOLs) designed for cataract surgery. The aim is to evaluate how these lenses perform in restoring vision and achieving spectacle independence for patients. Participants will undergo bilateral implantation of either the Evolux or Tecnis Eyhance IOLs, with assessments made on visual acuity and patient satisfaction. The study focuses on patients with cataracts who are seeking improved vision without reliance on glasses for intermediate and near tasks.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 and older with bilateral cataracts and sufficient visual acuity.
Not a fit: Patients with active ocular diseases or those requiring specific types of IOLs, such as toric lenses for astigmatism, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with improved vision and reduced dependence on glasses after cataract surgery.
How similar studies have performed: Previous studies have shown promising results with enhanced monofocal IOLs, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bilateral cataract * Age 21 or older * Visual acuity \> 0.05 * Axial length: 22.00-26.00mm * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Written informed consent prior to surgery * Availability, willingness and sufficient cognitive awareness to comply with examination procedures Exclusion Criteria: * Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication) * Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS) * Corneal decompensation or corneal endothelial cell insufficiency * Amblyopia * Previous ocular surgery or trauma * Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age) * Astigmatism with the need for a toric IOL
Where this trial is running
Vienna
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Oliver Findl, Prim. Dr. — Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus
- Study coordinator: Andreas Rotter, MD
- Email: office@viros.at
- Phone: 01 91021
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.