Comparing visual performance of a new intraocular lens for cataract patients
Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality
This study is testing a new type of eye lens for cataract patients to see if it can help them see clearly at different distances without needing glasses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (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 | NCT06624826 on ClinicalTrials.gov |
What this trial studies
This study evaluates the visual performance of a new refractive extended depth of focus intraocular lens (IOL) in patients with age-related bilateral cataracts. It compares two modalities: emmetropic and monovision, aiming to achieve spectacle independence for various distances. The study focuses on the lens's ability to provide a continuous range of vision, particularly for intermediate distances, while minimizing issues like dysphotopsia. Participants will undergo surgery and be monitored for visual outcomes post-implantation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with age-related bilateral cataracts and specific visual acuity requirements.
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 have shown promise with extended depth of focus IOLs, suggesting potential for success with this new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age-related bilateral cataract * Age 21 or older * Visual acuity \> 0.05 * Axial length: 21.00-27.00mm * 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) * 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 — Vienna, Austria, Austria (Recruiting)
Study contacts
- Principal investigator: Oliver Findl, Prim. Prof. 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.