An observational study in Cataract, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Recruiting at 2 sites in Austria. Open to participants aged 21 Years to 110 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Observational
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.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 80 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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80 cataract patients (160 eyes)
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Exclusion Criteria:
6) Zonular weakness 7) Pseudoexfoliation syndrome 8) Eccentric fixation or insufficient ability to fixate (tremor, nystagmus) 9) Pregnancy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aspheric monofocal
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
Refractive EDOF
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
Diffractive multifocal
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
Diffractive aspheric extended depth of focus
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
Enhanced monofocal
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
Enhanced monofocal
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
Rotationally asymmetric multifocal extended depth of focus
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
Refractive EDOF
Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)
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.
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)
Time frame: 24 months
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.
Time frame: 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
Time frame: 24 months
Non-dilated and dilated Pupil centration
Changes in pupil centration (unit: mm) will be evaluated before and after pharmacological dilation
Time frame: 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.
Time frame: 24 months
Plan to share: Undecided
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Prim. Prof. Dr. Oliver Findl, MBA