Irregular AstigmatismVITALNCT07294716
Improving Visual Quality in Patients With Irregular Corneas Using Asymmetrical Toric Intraocular Lenses
A study testing AMILens Individual in people with Irregular Astigmatism and Astigmatism, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
Cataract surgery in patients with irregular corneas presents unique challenges, primarily due to the high variability in keratometry and corneal tomography measurements, which complicates accurate intraocular lens (IOL) calculations. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Irregular Astigmatism, Astigmatism, Cataract and IOL Surgery
- What is being tested?
- AMILens Individual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 20 Jan 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Kepler University Clinic, Department for Ophthalmology and Optometry
Linz, 4020
Nino Hirnschall, MD, PhD, FEBO, MhBA, +43 (0)5 7680 83 73411, nino.hirnschall@kepleruniklinikum.at
About this study
Official title: VITAL - "Visual Improvement With Toric Asymmetrical Lenses": Enhancing Vision in Irregular Corneas
Cataract surgery in patients with irregular corneas presents unique challenges, primarily due to the high variability in keratometry and corneal tomography measurements, which complicates accurate intraocular lens (IOL) calculations. In these patients, therapeutic options are currently limited to either non-toric IOLs and rigid contact lenses postoperatively or conventional toric IOLs for the reduction of total astigmatism within cataract surgery. While conventional toric IOLs may be beneficial in selected cases with a stable astigmatic pattern and clear axis, their effectiveness is largely limited, as significant irregularity and higher order aberrations reduce predictability, accuracy of formulae, and refractive outcomes. Therefore, the development of a reliable method to reduce total astigmatism - including irregular components - would represent a major advancement, potentially improving both visual function and patient quality of life. The aim of this exploratory study is to evaluate the effectiveness of customized toric intraocular lenses (AMILens Individual, AMIPLANT GmbH, Germany) in reducing total corneal astigmatism in patients with a significant irregular astigmatic component. These lenses are designed to address corneal aberrations up to the 6th Zernike order, thereby extending correction beyond the capabilities of conventional toric IOLs. To our knowledge, no clinical study has yet investigated this novel approach.
- Conditions
- Irregular Astigmatism, Astigmatism, Cataract and IOL Surgery
- Being tested
- AMILens Individual
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMILens IndividualDevice
An acrylic hydrophilic, one piece 4-loop haptic, monofocal, toric IOL (AMILens Individual, AMIPLANT GmbH, Germany) will be implanted into the capsular bag after removal of the of the natural lens. This IOL is CE-certified. Asphericity and dioptric power of the IOL are customized for each individual eye.
| Study group | Role | What they receive |
|---|---|---|
| AMILens Individual Implantation | Active comparator | An acrylic hydrophilic, one piece 4-loop haptic, monofocal, toric IOL (AMILens Individual, AMIPLANT GmbH, Germany) will be implanted into the capsular bag after removal of the of the natural lens. This IOL is CE-certified. Asphericity and dioptric power of the IOL are customized for each individual eye. Receives: Device: AMILens Individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Astigmatism
The change of astigmatism is defined by the difference of the postoperative total refractive/ocular astigmatism (assessed via subjective refraction) to the preoperative corneal astigmatism (assessed via the utilized measurement devices).
Reduction in total ocular (refractive) astigmatism will be quantified as both absolute reduction (Diopter) and relative reduction (%). Descriptive statistics will include mean, standard deviation, median, interquartile range, and range. Normality will be tested using the Shapiro-Wilk test and Q-Q plots.
If normally distributed: comparisons between preoperative and postoperative values will be assessed with a paired t-test.
If not normally distributed: the Wilcoxon signed-rank test will be applied. Results will be presented with 95% confidence intervals. As this is an exploratory study, p-values will be reported descriptively, and values below 0.05 will not be interpreted as statistically significant.
Measured: 4-8 weeks post-surgery
Secondary outcomes (4)
Agreement of measured variables for astigmatism across devices
The agreement of the variables anterior corneal astigmatism, posterior corneal astigmatism, total corneal astigmatism, Zernike Polynomials first to seventh order, lower order aberrations (LOAs), and higher order aberrations (HOAs) are compared across the utilized measurement devices Pentacam, Anterion, ms39, and CASIA2. All mentioned variables are on a ratio scale.
Agreement between different devices will be assessed using: Bland-Altman analysis (mean difference and 95% limits of agreement),Intraclass correlation coefficients (ICCs) for reliability, and, where appropriate, repeated-measures ANOVA or Friedman test (non-parametric) across multiple modalities.
Measured: 4-8 weeks post cataract surgery
Change of higher order optical aberrations (HOAs)
Higher order optical abberation values are measured posoperatively for the whole eye (cornea and lens) with the osiris device, and compared to the preoperative corneal higher order abberations, which are measured with the Casia2 and the ms39 devices.
Reduction in higher order aberrations will be quantified as both absolute reduction (D) and relative reduction (%). The same descriptive statistics, normality testing, and comparison testing as described above will be applied. Results will be presented with 95% confidence intervals and p-values will be reported descriptively.
Measured: 4-8 weeks post cataract surgery
Surgically induced corneal astigmatism (SIA)
Surgically induced corneal astigmatism (SIA) will be evaluated by calculating the vectorial changes of corneal astigmatism (magnitude ind diopter and axis in degree) between preoperative and postoperative corneal astigmatism measurements for each measurement device
Measured: From enrollment to the end last study visit (4-8 weeks post surgery)
Postoperative uncorrected and best-corrected distance visual acuity
These values are assessed via standardized subjective refraction using the jackson cross cylinder method, and will be described descriptively in logMAR unit. Postoperative uncorrected and best-corrected visual acuity will be analyzed as both continuous variables and using threshold-based categories. Descriptive statistics will include mean, standard deviation, median, interquartile range, and range.
Measured: 4-8 weeks post cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start20 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irregular AstigmatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294716
- Sponsor's protocol ID
- KUK-Ophthalmology-017
- Acronym
- VITAL
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual data will not be made available to other researchers. Only the results will be shared in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITAL - "Visual Improvement With Toric Asymmetrical Lenses": Enhancing Vision in Irregular Corneas
- ClinicalTrials.gov ID
- NCT07294716
- Acronym / sponsor ID
- VITAL / KUK-Ophthalmology-017
- Conditions
- Irregular Astigmatism, Astigmatism, Cataract and IOL Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cataract surgery in patients with irregular corneas presents unique challenges, primarily due to the high variability in keratometry and corneal tomography measurements, which complicates accurate intraocular lens (IOL) calculations. In these patients, therapeutic options are currently limited to either non-toric IOLs and rigid contact lenses postoperatively or conventional toric IOLs for the reduction of total astigmatism within cataract surgery. While conventional toric IOLs may be beneficial in selected cases with a stable astigmatic pattern and clear axis, their effectiveness is largely limited, as significant irregularity and higher order aberrations reduce predictability, accuracy of formulae, and refractive outcomes. Therefore, the development of a reliable method to reduce total astigmatism - including irregular components - would represent a major advancement, potentially improving both visual function and patient quality of life. The aim of this exploratory study is to evaluate the effectiveness of customized toric intraocular lenses (AMILens Individual, AMIPLANT GmbH, Germany) in reducing total corneal astigmatism in patients with a significant irregular astigmatic component. These lenses are designed to address corneal aberrations up to the 6th Zernike order, thereby extending correction beyond the capabilities of conventional toric IOLs. To our knowledge, no clinical study has yet investigated this novel approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMILens Individual Implantation | Active comparator | Device: AMILens IndividualAn acrylic hydrophilic, one piece 4-loop haptic, monofocal, toric IOL (AMILens Individual, AMIPLANT GmbH, Germany) will be implanted into the capsular bag after removal of the of the natural lens. This IOL is CE-certified. Asphericity and dioptric power of the IOL are customized for each individual eye. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMILens IndividualAn acrylic hydrophilic, one piece 4-loop haptic, monofocal, toric IOL (AMILens Individual, AMIPLANT GmbH, Germany) will be implanted into the capsular bag after removal of the of the natural lens. This IOL is CE-certified. Asphericity and dioptric power of the IOL are customized for each individual eye. | Device | AMILens Individual Implantation |
Primary outcome
Change of Astigmatism
Time frame: 4-8 weeks post-surgery
The change of astigmatism is defined by the difference of the postoperative total refractive/ocular astigmatism (assessed via subjective refraction) to the preoperative corneal astigmatism (assessed via the utilized measurement devices). Reduction in total ocular (refractive) astigmatism will be quantified as both absolute reduction (Diopter) and relative reduction (%). Descriptive statistics will include mean, standard deviation, median, interquartile range, and range. Normality will be tested using the Shapiro-Wilk test and Q-Q plots. If normally distributed: comparisons between preoperative and postoperative values will be assessed with a paired t-test. If not normally distributed: the Wilcoxon signed-rank test will be applied. Results will be presented with 95% confidence intervals. As this is an exploratory study, p-values will be reported descriptively, and values below 0.05 will not be interpreted as statistically significant.
4 secondary outcomes
Agreement of measured variables for astigmatism across devices
Time frame: 4-8 weeks post cataract surgery
Change of higher order optical aberrations (HOAs)
Time frame: 4-8 weeks post cataract surgery
Surgically induced corneal astigmatism (SIA)
Time frame: From enrollment to the end last study visit (4-8 weeks post surgery)
Postoperative uncorrected and best-corrected distance visual acuity
Time frame: 4-8 weeks post cataract surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. The individual data will not be made available to other researchers. Only the results will be shared in peer-reviewed journals.
Related trials for Irregular Astigmatism
Active, not recruiting
Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (New Approach)
Irregular Astigmatism
Recruiting
Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus
Keratoconus, Irregular Astigmatism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kepler University Clinic, Department for Ophthalmology and Optometry
Linz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMILens Individual in people with Irregular Astigmatism and Astigmatism, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Astigmatism (time frame: 4-8 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.