Using asymmetrical toric intraocular lenses to improve vision for people with irregular corneas
Official title: VITAL - "Visual Improvement With Toric Asymmetrical Lenses": Enhancing Vision in Irregular Corneas
Run by Johannes Kepler University of Linz · NCT07294716 · Data updated 2026-11-12
This will test a custom asymmetrical toric intraocular lens during cataract surgery to reduce irregular astigmatism and improve vision in adults with irregular corneas.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Johannes Kepler University of Linz Academic / other |
| Locations | 1 site (Linz) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT07294716 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21 or older scheduled for cataract surgery with CASIA2-measured total astigmatism ≥1.75 D and ≥0.75 D of asymmetry or higher-order irregularity within the 6 mm corneal zone.
✕Probably not a fit
Patients with relevant central corneal scars, pseudoexfoliation (PEX), prior ocular surgery or severe trauma, combined surgical procedures, an unstable capsular bag, expected postoperative BCVA below 0.3 Snellen, or who are pregnant are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Cataract surgery in eyes with irregular corneas is challenging because variable keratometry and corneal tomography make IOL power and astigmatism calculations unpredictable. This exploratory interventional protocol implants a custom asymmetrical toric intraocular lens (AMILens Individual) to target total astigmatism, including irregular components identified on CASIA2 corneal maps. Eligible participants are adults with at least 1.75 D total astigmatism and at least 0.75 D of asymmetry or higher-order irregularity within the central 6 mm zone; key exclusions include central corneal scars, prior ocular surgery, pseudoexfoliation or any condition risking an unstable capsular bag. Outcomes will focus on refractive results, visual acuity, and postoperative stability at a single center in Linz, Austria.
Why it matters
Potential benefit: If successful, the lens could reduce irregular astigmatism at the time of cataract surgery and improve uncorrected vision and quality of life for affected patients.
How similar studies have gone: Conventional toric IOLs have shown benefit for regular astigmatism, but using asymmetrical toric lenses to correct irregular astigmatism is relatively novel with limited published data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 21 years or older * Scheduled cataract surgery * At least 1.75 D of total astigmatism in the CASIA2 measurement * At least 0.75 D of asymmetry or higher order irregularity within the 6mm zone of the real (total) index corneal refractive map of the CASIA2 measurements Exclusion Criteria: * Relevant central corneal scars * PEX, previous ocular surgery, severe trauma or any pathology that could lead to an unstable capsular bag * Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery) * Postoperative best corrected distance visual acuity below 0.3 Snellen decimal * Pregnancy
Where it's running
-
Kepler University Clinic, Department for Ophthalmology and Optometry
Linz, Austria Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.