Comparing five extended-depth-of-focus intraocular lenses and one standard monofocal lens for cataract surgery
Visual Performance, Patient Satisfaction, and Quality of Vision Outcomes in Presbyopia-Correcting IOLs: A Prospective Clinical Study
This test compares five extended-depth-of-focus intraocular lenses and one standard monofocal lens in adults having cataract surgery in both eyes to see which provides the best distance, intermediate, and near vision and reduces the need for glasses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 22 Years to 85 Years |
| Sex | All |
| Sponsor | Augenklinik Ahaus G + H GmbH & Co. KG Academic / other |
| Locations | 1 site (Ahaus, North Rhine-Westphalia) |
| Trial ID | NCT07051720 on ClinicalTrials.gov |
What this trial studies
This prospective, interventional comparison enrolls adults undergoing bilateral cataract surgery who receive one of six intraocular lens (IOL) models implanted in both eyes. The five enhanced-depth-of-focus (EDOF) lenses (TECNIS Eyhance, AcrySof IQ Vivity, LuxSmart, Rayner EMV, Eyecryl SERT) are compared head-to-head against a standard monofocal lens (CT ASPHINA 409M). Outcomes include uncorrected and best-corrected visual acuity at multiple distances, patient-reported satisfaction, and spectacle dependence. Participants must meet ocular health criteria such as regular corneal astigmatism <1.0 D and be within the available IOL power range.
Who should consider this trial
Good fit: Adults aged 22 to 85 requiring bilateral cataract surgery with regular corneal astigmatism under 1.0 diopter and expected postoperative BCDVA of 0.8 decimal or better are the ideal candidates.
Not a fit: Patients with prior corneal refractive surgery, irregular astigmatism, significant ocular comorbidities, pupillary abnormalities, or IOL power needs outside +10.0 D to +30.0 D are unlikely to be eligible or to benefit from the lenses tested.
Why it matters
Potential benefit: If successful, the trial could identify which lens designs give the best range of clear vision and reduce reliance on glasses after cataract surgery.
How similar studies have performed: Previous studies comparing EDOF and monofocal IOLs have generally reported improved intermediate vision and reduced spectacle dependence with EDOF designs, but direct head-to-head comparisons across these specific lenses are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bilateral implantation of the same intraocular lens (IOL) model * Expected postoperative best-corrected distance visual acuity (BCDVA) of 0.8 (decimal) or better * Regular corneal astigmatism less than 1 diopter Exclusion Criteria: * Endothelial cell density \< 2,000 cells/mm² * Required IOL power for emmetropia falls outside the available range of +10.0 D to +30.0 D * Pupillary abnormalities * Intraocular inflammation * Recent ocular trauma or ocular surgery that is unresolved/unstable, or which may impair visual outcomes or increase patient risk * History of corneal refractive surgery (e.g., LASIK, LASEK, PRK) * Irregular astigmatism, as well as corneal abnormalities or opacities * Conditions associated with an increased risk of zonular rupture, including capsular or zonular anomalies that may lead to IOL decentration or tilt, such as pseudoexfoliation syndrome, trauma, Marfan syndrome, among others * Systemic or ocular diseases, or medications, that may impair vision, increase surgical risk, or confound study outcomes * Clinically significant dry eye disease affecting visual function * Anticipated need for retinal laser treatment or any other ocular surgical intervention during the study period * Pregnancy, planned pregnancy, breastfeeding, or any condition associated with hormonal fluctuations that may induce refractive changes * Continuous contact lens wear within the past 4 weeks * Inability to understand and/or complete study questionnaires * Advanced glaucoma with visual field defects * Age-related macular degeneration (exudative or geographic form)
Where this trial is running
Ahaus, North Rhine-Westphalia
- Augenklinik Ahaus — Ahaus, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: dr. med. (Univ. Bud.) Matthias Gerl, MD — Augenklinik Ahaus
- Study coordinator: dr. med. (Univ. Bud.) Matthias Gerl, MD
- Email: m.gerl@augenklinik.de
- Phone: +49 (2561) 9555-301
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.