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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acrysoft SN60WF (Alcon) - Control | Aspheric monofocal |
| |
| Acrysoft IQ Vivity (Alcon) | Refractive EDOF |
| |
| AT Lisa Tri (Carl Zeiss Meditec AG) | Diffractive multifocal |
| |
| Tecnis Symphony ZXR00 (Johnson & Johnson) | Diffractive aspheric extended depth of focus |
| |
| Tecnis Eyhance ICB00 (Johnson & Johnson) | Enhanced monofocal |
| |
| RayOne EMV (Rayner Surgical) | Enhanced monofocal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
6) Zonular weakness 7) Pseudoexfoliation syndrome 8) Eccentric fixation or insufficient ability to fixate (tremor, nystagmus) 9) Pregnancy
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80 cataract patients (160 eyes)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Georgiev, MD, PhD | Contact | +43 1 91021 | 57564 | office@viros.at |
| Oliver Findl, Prof., Dr. | Contact | +43 1 91021 | 57564 | office@viros.at |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Findl, Prof., Dr. | Vienna Institute for Research in Ocular Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna | Recruiting | Vienna | 1140 | Austria |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Acunex Varo AN6V (Teleon Surgical) | Rotationally asymmetric multifocal extended depth of focus |
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| PureSee (Johnson & Johnson) | Refractive EDOF |
|
| RayOne Trifocal (Rayner) | Diffractive Multifocal |
|
|
| 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 |
| Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna | Recruiting | Vienna | 1140 | Austria |
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