Comparing two types of intraocular lenses for cataract surgery
Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
This study is testing two different types of lenses used in cataract surgery to see which one helps patients see better at different distances after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 105 Years |
| Sex | All |
| Sponsor | Vienna Institute for Research in Ocular Surgery Academic / other |
| Locations | 1 site (Vienna, Austria) |
| Trial ID | NCT06607848 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the visual performance of two extended depth of focus (EDOF) intraocular lenses (IOLs), the PureSee and Acunex Vario, in patients undergoing cataract surgery. The research will involve an intra-individual comparison, where both lenses will be implanted in the same patient to assess their effectiveness in providing clear vision at various distances. The study will include 40 patients and will evaluate visual outcomes one week before surgery and again at one week and four to six months post-operation. The goal is to enhance spectacle independence and reduce visual disturbances associated with traditional lenses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with age-related bilateral cataracts and adequate visual acuity.
Not a fit: Patients with active ocular diseases or significant prior ocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved visual outcomes and reduced reliance on glasses for patients with cataracts.
How similar studies have performed: Previous studies on EDOF lenses have shown promising results, indicating potential for success in this comparative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age-related bilateral cataract * Age 21 or older * Visual acuity \> 0.05 * For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant * Written informed consent prior to surgery Exclusion Criteria: * Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity * Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX) * Corneal decompensation or corneal endothelial cell insufficiency * Irregular astigmatism on corneal tomography * Pronounced dry eye disease * Previous ocular surgery or trauma * Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
Where this trial is running
Vienna, Austria
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna — Vienna, Austria, Austria (Recruiting)
Study contacts
- Principal investigator: Oliver Findl, Univ. Prof. Prim. Dr. — Vienna Institute for Research in Ocular Surgery (VIROS)
- Study coordinator: Johannes Zeilinger, MD
- Email: office@viros.at
- Phone: 01 91021 57564
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.