Intraocular Lens Calculation Using Artificial Intelligence

NCT07202767 | Not Yet Recruiting DMC

• 1 other identifier: KUK-Ophthalmology-015
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the lens diameter (LD) as a useful parameter in intraocular lens (IOL) power calculation by using several different non-invasive imaging techniques. The aim is to establish an accurate model for lens diameter estimation and subsequently evaluate the influence of the LD on the effective postoperative lens position. The comparability of the different devices in terms of variability between the biometric measurements will also be assessed. By then combining these two approaches with artificial intelligence, the aim is to develop a new approach to effectively incorporate the LD in IOL power calculation and improve patient's outcome in the long run.

Conditions

Cataract

Keywords

cataract; lens diameter; artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Prediction model to estimate lens diameter with different measurement tools (swept-AS segment OCT; anterior segment-OCT and Placido topography with OCT-based anterior segment tomography; wave-front abberometry; swept-source OCT and optical biometer)

  Developing a prediction model to accurately estimate the lens diameter using biometric parameters (swept-source anterior segment Optical Coherence Topography (Casia-2), Placido topography combined with Optical Coherenece Topography-based anterior segment tomography (MS-39), wave-front abberometry (OSIRIS), Swept-Source Optical Coherence Tomography (IOLMaster 700) and anterior segment swept-source OCT (Anterion).

  preoperatively, 4 and 12 weeks post cataract surgery

• Prediction model to estimate lens diameter with cerebral Magnetic Resonance Imaging

  Developing a prediction model to accurately estimate the lens diameter using cerebral Magnetic Resonance Imaging to examine ocular configuration

  12 weeks post cataract surgery

Secondary Outcomes (2)

• IOL calculation concept an artificial intelligence approach

  preoperatively, 4 and 12 weeks post cataract surgery

• Different measurement modalities for the biometry of the eye

  4 and 12 weeks post cataract surgery

Study Arms (2)

Study Cohort with MRI

Patients who are included in this study who additionally receive a cerebral MRI

Device: Swept-Source Anterior Segment OCT

Study cohort without MRI

Study cohort who doesn't receive an MRI

Device: Swept-Source Anterior Segment OCT

Interventions

Swept-Source Anterior Segment OCT DEVICE

Device: Swept-Source Anterior Segment OCT The CASIA-2 (Tomey, Japan) is a high-resolution swept-source anterior segment OCT with CE certification. The device allows for incomplete visualization of the lens, including the anterior and posterior lens curvature. Device: AS-OCT + Placido disc corneal topography The MS-39 (CSO, Italy) is a non-invasive device that combines Placido topography with OCT-based anterior segment tomography. Device: Wave-front abberomtery The OSIRIS aberrometer is a standard tool for examining corneal aberration and measuring the ocular wavefront. Device: Swept-Source OCT The IOLMaster 700 (Carl Zeiss Meditec, Germany) is a standard swept-source OCT used for eye examinations. Device: AS-OCT The ANTERION (Heidelberg Engineering, Germany) is an anterior segment swept-source OCT. Diagnostic Test: Refraction Subjective Refraction evaluation using the cross-cylinder method

Study Cohort with MRI; Study cohort without MRI

Eligibility Criteria

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

Study Population

The participants will be selected at Kepler University Clinic Linz at the Departement of Ophthalmology and Optometry.

You may qualify if:

• age 21 years and older
• planned uncomplicated bilateral cataract surgery
• availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
• ability to consent to the participation in the study
• signed informed consent

You may not qualify if:

• multifocal IOL
• combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
• PEX, previous ocular surgery, severe trauma or any pathology that could lead to an unstable capsular bag
• glaucoma or any other retinal disease that may affect visual acuity significantly
• pregnancy
• pre-operative visual acuity below 0.1 Snellen decimal (1.0 Log MAR)
• pupil diameter \<4mm

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead

Study Sites (1)

Kepler University Clinic, Linz

Linz, 4020, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Nino Hirnschall, MD PhD

  JKU Linz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nino Hirnschall, MD PhD

CONTACT

0043(0)5768083; nino.hirnschall@kepleruniklinikum.at

Leon Pomberger, MD

CONTACT

0043(0)5768083; leon.pomberger@kepleruniklinikum.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

AU (1)