CataractNCT07436247
Pseudophakic Eyes With Presbyopia-correcting IOLs: OCT Biometry and Pyramid Aberrometry
An observational study of Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 2 sites in Austria.
Trial summary
To correlate ocular morphology from anterior segment OCT and pyramid wavefront sensing in order to comprehensively analyze pseudophakic in vivo image quality of presbyopia-correcting IOLs in cataract patients. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Cataract
- What is being tested?
- Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 2 sitesAustria
- Study dates
- 4 Apr 2024to 1 Jul 2026
- Phase
- Observational
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 cataract patients (160 eyes)
Who may be able to join
- Men and women aged above 21 years with prior uncomplicated cataract/IOL exchange surgery
- Willing to sign informed consent before measurements
- Corrected distance visual acuity (CDVA) of 0.1 logMAR or better
- Absence of corneal scars/dry eye disease that could falsify the light transmission of the study eye
- Total absence of posterior capsule opacification or patients who already have undergone Nd:YAG capsulotomy
- Absence of ocular comorbidity (Macular degeneration, glaucoma, amblyopia)
Who cannot join
- Prior corneal refractive or ocular surgery
- Posterior capsule opacification.
- Keratometry between <42.5 and >45 D,
- Corneal spherical aberration > 0.4 microns 5) Angle kappa > 0.4 mm
- 6) Zonular weakness 7) Pseudoexfoliation syndrome 8) Eccentric fixation or insufficient ability to fixate (tremor, nystagmus) 9) Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
Stefan Georgiev, MD, PhD, +43 1 91021
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
Stefan Georgiev, MD, PhD, +43 1 91021 ext. 57564, office@viros.at
Oliver Findl, Prof., Dr., +43 1 91021 ext. 57564, office@viros.at
About this study
Official title: Pseudophakic Eyes Implanted With Different Presbyopia-correcting IOL Designs: 3-D Anterior Segment OCT Biometry and Pyramid Wavefront Sensing- Based Retinal Image Quality
To correlate ocular morphology from anterior segment OCT and pyramid wavefront sensing in order to comprehensively analyze pseudophakic in vivo image quality of presbyopia-correcting IOLs in cataract patients.
Read the detailed description
Improvements in cataract surgery and the introduction of different intraocular lenses (IOLs) have transformed the operation from a simple therapeutic procedure to a refractive surgical procedure. A large number of currently available IOL designs are not limited to correcting refractive errors and astigmatism, but can also compensate for corneal sphericity and/or moderate presbyopia by inducing multifocality or extending the depth of focus.
The three-dimensional representation of the anterior segment of the eye has been facilitated in eye surgery by the introduction of optical coherence tomography (OCT), and imaging techniques such as spectral domain OCT (SD-OCT) and swept-source OCT (SS OCT) are particularly well suited for the quantitative characterization of eye dimensions. This offers the possibility of creating biometric eye models and using the non-paraxial regime for characterizing eye optics.
Similarly, the introduction of ocular wavefront aberrometry at the turn of the millennium led to a paradigm shift in the evaluation of clinical optical imaging quality and the derivation of objective optical metrics. Furthermore, internal lens aberrations can be quantified by direct subtraction from anterior segment tomography. However, high-resolution eye tomography and wavefront aberrometry are rarely comprehensively linked.
A pyramidal wavefront sensor (PWS) Osiris-T (CSO, Italy) was recently introduced, which can measure the ocular wavefront with a significantly higher lateral resolution. In addition, tomographic parameters of the anterior segment can be imported directly into the device to examine the clinical optical performance of IOL implants. This provides the ability to combine 3-D OCT biometry of the anterior segment and high-resolution wavefront aberrometry.
A total of 160 eyes of 80 patients will be included.
- Conditions
- Cataract
- Being tested
- Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
- Keywords
- Intraocular Lenses, Pyramid wavefront, Pyramid Aberrometry
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Device
The Osiris-T aberrometer is a CE-certified device that operates via a high-resolution four-faced pyramid wavefront sensor (PWS) to analyze light intensity among four images (sub-apertures) of the patients ́entrance pupil akin to a Foucault knife-edge test. Thereby measurements of the wavefront and refractive error can be quantified non-invasively. The sampling density of the wavefront error is 45,000 points at maximum pupil. The device uses a near-infrared extended light-emitting diode source emitting at 850 nm. Its is additionally intertwined with a corneal topography system to also characterize the corneal aberrations and compute via direct subtraction the internal ocular optics.
| Study group | Role | What they receive |
|---|---|---|
| Acrysoft SN60WF (Alcon) - Control | Aspheric monofocal Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| Acrysoft IQ Vivity (Alcon) | Refractive EDOF Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| AT Lisa Tri (Carl Zeiss Meditec AG) | Diffractive multifocal Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| Tecnis Symphony ZXR00 (Johnson & Johnson) | Diffractive aspheric extended depth of focus Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| Tecnis Eyhance ICB00 (Johnson & Johnson) | Enhanced monofocal Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| RayOne EMV (Rayner Surgical) | Enhanced monofocal Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| Acunex Varo AN6V (Teleon Surgical) | Rotationally asymmetric multifocal extended depth of focus Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| PureSee (Johnson & Johnson) | Refractive EDOF Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) | |
| RayOne Trifocal (Rayner) | Diffractive Multifocal Receives: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL ocular optics measument
To measure the internal ocular optics of patients with presbyopia-correcting IOLs via 3-D anterior segment OCT biometry and pyramid wavefront sensing by employing the following optical metrics higher-order aberrations (HOAs, unit: root means square)
Measured: 24 months
Secondary outcomes (4)
Comparison of clinical optical quality and device measurements
Correlate and compare clinical optical quality via defocus curves (by employing trial lenses to the best distance prescription, starting from +0.50 to -3.00 diopters (D), in -0.50-D steps) to virtual ray traced aberrations from anterior segment OCT as well as physically measured wavefront aberrations with the pyramid wavefront sensor. Wavefront data will thereby be also employed to analyze the fidelity of virtual ray traced aberrations from anterior segment OCT and measured wavefront aberrations with the pyramid wavefront sensor.
Measured: 24 months
Higher-order aberrations in non-dilated and dilated pupils
Changes in higher-order aberrations (unit: root mean square) will be evaluated before and after pharmacological dilation of pupils
Measured: 24 months
Non-dilated and dilated Pupil centration
Changes in pupil centration (unit: mm) will be evaluated before and after pharmacological dilation
Measured: 24 months
Correlation and Comparison of IOL decentration
Correlate and compare IOL decentration measured with the pyramid-wavefront sensor to IOL decentration and tilt measured with 3-D anterior segment OCT.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start4 Apr 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof., Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436247
- Sponsor's protocol ID
- IOLs and pyramid aberrometry
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudophakic Eyes Implanted With Different Presbyopia-correcting IOL Designs: 3-D Anterior Segment OCT Biometry and Pyramid Wavefront Sensing- Based Retinal Image Quality
- ClinicalTrials.gov ID
- NCT07436247
- Acronym / sponsor ID
- IOLs and pyramid aberrometry
- Conditions
- Cataract
- Keywords
- Intraocular Lenses, Pyramid wavefront, Pyramid Aberrometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
To correlate ocular morphology from anterior segment OCT and pyramid wavefront sensing in order to comprehensively analyze pseudophakic in vivo image quality of presbyopia-correcting IOLs in cataract patients.
Detailed description
Improvements in cataract surgery and the introduction of different intraocular lenses (IOLs) have transformed the operation from a simple therapeutic procedure to a refractive surgical procedure. A large number of currently available IOL designs are not limited to correcting refractive errors and astigmatism, but can also compensate for corneal sphericity and/or moderate presbyopia by inducing multifocality or extending the depth of focus.
The three-dimensional representation of the anterior segment of the eye has been facilitated in eye surgery by the introduction of optical coherence tomography (OCT), and imaging techniques such as spectral domain OCT (SD-OCT) and swept-source OCT (SS OCT) are particularly well suited for the quantitative characterization of eye dimensions. This offers the possibility of creating biometric eye models and using the non-paraxial regime for characterizing eye optics.
Similarly, the introduction of ocular wavefront aberrometry at the turn of the millennium led to a paradigm shift in the evaluation of clinical optical imaging quality and the derivation of objective optical metrics. Furthermore, internal lens aberrations can be quantified by direct subtraction from anterior segment tomography. However, high-resolution eye tomography and wavefront aberrometry are rarely comprehensively linked.
A pyramidal wavefront sensor (PWS) Osiris-T (CSO, Italy) was recently introduced, which can measure the ocular wavefront with a significantly higher lateral resolution. In addition, tomographic parameters of the anterior segment can be imported directly into the device to examine the clinical optical performance of IOL implants. This provides the ability to combine 3-D OCT biometry of the anterior segment and high-resolution wavefront aberrometry.
A total of 160 eyes of 80 patients will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Acrysoft SN60WF (Alcon) - Control | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Aspheric monofocal |
| Acrysoft IQ Vivity (Alcon) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Refractive EDOF |
| AT Lisa Tri (Carl Zeiss Meditec AG) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Diffractive multifocal |
| Tecnis Symphony ZXR00 (Johnson & Johnson) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Diffractive aspheric extended depth of focus |
| Tecnis Eyhance ICB00 (Johnson & Johnson) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Enhanced monofocal |
| RayOne EMV (Rayner Surgical) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Enhanced monofocal |
| Acunex Varo AN6V (Teleon Surgical) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Rotationally asymmetric multifocal extended depth of focus |
| PureSee (Johnson & Johnson) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Refractive EDOF |
| RayOne Trifocal (Rayner) | – | Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)Diffractive Multifocal |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 cataract patients (160 eyes)
Key inclusion criteria (6 listed)
- Men and women aged above 21 years with prior uncomplicated cataract/IOL exchange surgery
- Willing to sign informed consent before measurements
- Corrected distance visual acuity (CDVA) of 0.1 logMAR or better
- Absence of corneal scars/dry eye disease that could falsify the light transmission of the study eye
- Total absence of posterior capsule opacification or patients who already have undergone Nd:YAG capsulotomy
Key exclusion criteria (5 listed)
- Prior corneal refractive or ocular surgery
- Posterior capsule opacification.
- Keratometry between <42.5 and >45 D,
- Corneal spherical aberration > 0.4 microns 5) Angle kappa > 0.4 mm
- 6) Zonular weakness 7) Pseudoexfoliation syndrome 8) Eccentric fixation or insufficient ability to fixate (tremor, nystagmus) 9) 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 |
|---|---|---|
| Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)The Osiris-T aberrometer is a CE-certified device that operates via a high-resolution four-faced pyramid wavefront sensor (PWS) to analyze light intensity among four images (sub-apertures) of the patients ́entrance pupil akin to a Foucault knife-edge test. Thereby measurements of the wavefront and refractive error can be quantified non-invasively. The sampling density of the wavefront error is 45,000 points at maximum pupil. The device uses a near-infrared extended light-emitting diode source emitting at 850 nm. Its is additionally intertwined with a corneal topography system to also characterize the corneal aberrations and compute via direct subtraction the internal ocular optics. | Device | AT Lisa Tri (Carl Zeiss Meditec AG), Acrysoft IQ Vivity (Alcon), Acrysoft SN60WF (Alcon) - Control, Acunex Varo AN6V (Teleon Surgical), PureSee (Johnson & Johnson), RayOne EMV (Rayner Surgical), RayOne Trifocal (Rayner), Tecnis Eyhance ICB00 (Johnson & Johnson), Tecnis Symphony ZXR00 (Johnson & Johnson) |
Primary outcome
IOL ocular optics measument
Time frame: 24 months
To measure the internal ocular optics of patients with presbyopia-correcting IOLs via 3-D anterior segment OCT biometry and pyramid wavefront sensing by employing the following optical metrics higher-order aberrations (HOAs, unit: root means square)
4 secondary outcomes
Comparison of clinical optical quality and device measurements
Time frame: 24 months
Higher-order aberrations in non-dilated and dilated pupils
Time frame: 24 months
Non-dilated and dilated Pupil centration
Time frame: 24 months
Correlation and Comparison of IOL decentration
Time frame: 24 months
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Oliver Findl, Prof., Dr. principal investigator
Vienna Institute for Research in Ocular Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 2 sites 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 6 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Stefan Georgiev, MD, PhD (+43 1 91021 ext. 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL ocular optics measument (time frame: 24 months). 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 27 Feb 2026.