Pseudophakic Eyes With Presbyopia-correcting IOLs: OCT Biometry and Pyramid Aberrometry

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Stefan Georgiev, MD, PhD; Phone Number: 57564 +43 1 91021; Email: office@viros.at
• Study Contact Backup: Name: Oliver Findl, Prof., Dr.; Phone Number: 57564 +43 1 91021; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
    • Contact: Stefan Georgiev, MD, PhD; Phone Number: 57564 +43 1 91021; Email: office@viros.at
    • Contact: Oliver Findl, Prof., Dr.; Phone Number: 57564 +43 1 91021; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

80 cataract patients (160 eyes)

Description

Inclusion Criteria:

1. Men and women aged above 21 years with prior uncomplicated cataract/IOL exchange surgery
2. Willing to sign informed consent before measurements
3. Corrected distance visual acuity (CDVA) of 0.1 logMAR or better
4. Absence of corneal scars/dry eye disease that could falsify the light transmission of the study eye
5. Total absence of posterior capsule opacification or patients who already have undergone Nd:YAG capsulotomy
6. Absence of ocular comorbidity (Macular degeneration, glaucoma, amblyopia)

Exclusion Criteria:

1. Prior corneal refractive or ocular surgery
2. Posterior capsule opacification.
3. Keratometry between <42.5 and >45 D,
4. 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

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acrysoft SN60WF (Alcon) - Control; Aspheric monofocal	Device: 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.
Acrysoft IQ Vivity (Alcon); Refractive EDOF	Device: 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.
AT Lisa Tri (Carl Zeiss Meditec AG); Diffractive multifocal	Device: 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.
Tecnis Symphony ZXR00 (Johnson & Johnson); Diffractive aspheric extended depth of focus	Device: 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.
Tecnis Eyhance ICB00 (Johnson & Johnson); Enhanced monofocal	Device: 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.
RayOne EMV (Rayner Surgical); Enhanced monofocal	Device: 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.
Acunex Varo AN6V (Teleon Surgical); Rotationally asymmetric multifocal extended depth of focus	Device: 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.
PureSee (Johnson & Johnson); Refractive EDOF	Device: 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.
RayOne Trifocal (Rayner); Diffractive Multifocal	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	24 months
Non-dilated and dilated Pupil centration	Changes in pupil centration (unit: mm) will be evaluated before and after pharmacological dilation	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.	24 months

Collaborators and Investigators

• Sponsor: Prim. Prof. Dr. Oliver Findl, MBA
• Investigators: Principal Investigator: Oliver Findl, Prof., Dr., Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intraocular Lenses; Pyramid wavefront; Pyramid Aberrometry
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: IOLs and pyramid aberrometry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No