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Trials / Recruiting

RecruitingNCT07436247

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
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA · Academic / Other
Sex
All
Age
21 Years – 110 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2024-04-04
Primary completion
2026-04-01
Completion
2026-07-01
First posted
2026-02-27
Last updated
2026-02-27

Locations

2 sites across 1 country: Austria

Source: ClinicalTrials.gov record NCT07436247. Inclusion in this directory is not an endorsement.