Using asymmetrical toric intraocular lenses to improve vision for people with irregular corneas
VITAL - "Visual Improvement With Toric Asymmetrical Lenses": Enhancing Vision in Irregular Corneas
NA · Johannes Kepler University of Linz · NCT07294716
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Johannes Kepler University of Linz (other) |
| Locations | 1 site (Linz) |
| Trial ID | NCT07294716 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Linz
- Kepler University Clinic, Department for Ophthalmology and Optometry — Linz, Austria (RECRUITING)
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.
Conditions: Irregular Astigmatism, Astigmatism, Cataract and IOL Surgery