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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07436247
Enrollment
80
Registered
2026-02-27
Start date
2024-04-04
Completion date
2026-07-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Intraocular Lenses, Pyramid wavefront, Pyramid Aberrometry

Brief 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.

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.

Interventions

DEVICEOsiris-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.

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 110 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IOL ocular optics measument24 monthsTo 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)

Secondary

MeasureTime frameDescription
Comparison of clinical optical quality and device measurements24 monthsCorrelate 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.
Higher-order aberrations in non-dilated and dilated pupils24 monthsChanges in higher-order aberrations (unit: root mean square) will be evaluated before and after pharmacological dilation of pupils
Non-dilated and dilated Pupil centration24 monthsChanges in pupil centration (unit: mm) will be evaluated before and after pharmacological dilation
Correlation and Comparison of IOL decentration24 monthsCorrelate and compare IOL decentration measured with the pyramid-wavefront sensor to IOL decentration and tilt measured with 3-D anterior segment OCT.

Countries

Austria

Contacts

CONTACTStefan Georgiev, MD, PhD
office@viros.at+43 1 91021
CONTACTOliver Findl, Prof., Dr.
office@viros.at+43 1 91021
PRINCIPAL_INVESTIGATOROliver Findl, Prof., Dr.

Vienna Institute for Research in Ocular Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026