Pseudophakic Eyes With Presbyopia-correcting IOLs: OCT Biometry and Pyramid Aberrometry
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy).
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: 21 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pseudophakic Eyes Implanted With Different Presbyopia-correcting IOL Designs: 3-D Anterior Segment OCT Biometry and Pyramid Wavefront Sensing- Based Retinal Image Quality
Overview
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
- 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 em
Primary outcome measures
- IOL ocular optics measument [Time frame: 24 months]
Secondary outcome measures (4)
- Comparison of clinical optical quality and device measurements [Time frame: 24 months]
- Higher-order aberrations in non-dilated and dilated pupils [Time frame: 24 months]
- Non-dilated and dilated Pupil centration [Time frame: 24 months]
- Correlation and Comparison of IOL decentration [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Men and women aged above 21 years with prior uncomplicated cataract/IOL exchange surgery
- Willing to sign informed consent before measurements
- Corrected distance visual acuity (CDVA) of 0.1 logMAR or better
- Absence of corneal scars/dry eye disease that could falsify the light transmission of the study eye
- Total absence of posterior capsule opacification or patients who already have undergone Nd:YAG capsulotomy
- Absence of ocular comorbidity (Macular degeneration, glaucoma, amblyopia)
Exclusion criteria
- Prior corneal refractive or ocular surgery
- Posterior capsule opacification.
- Keratometry between <42.5 and >45 D,
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 2 centers
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna — Vienna
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna — Vienna
Identifiers
NCT: NCT07436247 · IOLs and pyramid aberrometry