Pseudophakic Eyes With Presbyopia-correcting IOLs: OCT Biometry and Pyramid Aberrometry

NCT07436247 | Recruiting

• 1 other identifier: IOLs and pyramid aberrometry
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Cataract

Keywords

Intraocular Lenses; Pyramid wavefront; Pyramid Aberrometry

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Comparison of clinical optical quality and device measurements

  24 months

• Higher-order aberrations in non-dilated and dilated pupils

  24 months

• Non-dilated and dilated Pupil centration

  24 months

• Correlation and Comparison of IOL decentration

  24 months

Study Arms (9)

Acrysoft SN60WF (Alcon) - Control

Aspheric monofocal

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

Acrysoft IQ Vivity (Alcon)

Refractive EDOF

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

AT Lisa Tri (Carl Zeiss Meditec AG)

Diffractive multifocal

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

Tecnis Symphony ZXR00 (Johnson & Johnson)

Diffractive aspheric extended depth of focus

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

Tecnis Eyhance ICB00 (Johnson & Johnson)

Enhanced monofocal

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

RayOne EMV (Rayner Surgical)

Enhanced monofocal

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

Acunex Varo AN6V (Teleon Surgical)

Rotationally asymmetric multifocal extended depth of focus

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

PureSee (Johnson & Johnson)

Refractive EDOF

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

RayOne Trifocal (Rayner)

Diffractive Multifocal

Device: Osiris-T Pyramid Wavefront Sensor - (CSO, Italy)

Interventions

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.

AT Lisa Tri (Carl Zeiss Meditec AG); Acrysoft IQ Vivity (Alcon); Acrysoft SN60WF (Alcon) - Control; Acunex Varo AN6V (Teleon Surgical); PureSee (Johnson & Johnson); RayOne EMV (Rayner Surgical); RayOne Trifocal (Rayner); Tecnis Eyhance ICB00 (Johnson & Johnson); Tecnis Symphony ZXR00 (Johnson & Johnson)

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

80 cataract patients (160 eyes)

You may qualify if:

• 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)

You may not qualify if:

• 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
• \) Zonular weakness 7) Pseudoexfoliation syndrome 8) Eccentric fixation or insufficient ability to fixate (tremor, nystagmus) 9) Pregnancy

Sponsors & Collaborators

• Prim. Prof. Dr. Oliver Findl, MBA: lead

Study Sites (2)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, 1140, Austria

RECRUITING

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Oliver Findl, Prof., Dr.

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Georgiev, MD, PhD

CONTACT

+43 1 91021; office@viros.at

Oliver Findl, Prof., Dr.

CONTACT

+43 1 91021; office@viros.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 27, 2026
• Study Start: April 4, 2024
• Primary Completion: April 1, 2026
• Study Completion: July 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

AU (2)