Intraocular Lens Calculation Using Artificial Intelligence

NCT ID: NCT07202767

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-10-30

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.

Detailed Description

During uncomplicated cataract operation, the clouded natural lens is being removed and replaced with an artificial intraocular lens (IOL). To achieve optimal postoperative outcomes for patients, the power of the implanted artificial lens is calculated prior to surgery.

Significant progress has been made in calculation concepts over the past 20 years, including the introduction of regression, vergence and ray tracing. More recently, approaches incorporating artificial intelligence have emerged.

All these formulae are based on the biometric data of the eye. This includes parameters such as axial eye length, corneal curvature, central corneal thickness, anterior chamber depth and the refractive indices of the eye's optical segments. By including all these variables, modern formulas aim to deliver the best possible postoperative outcomes.

One variable that has not been included in the calculation thus far is the diameter of the natural lens. Large parts of the lens are covered by the iris. Even with medically dilated pupils the peripheral parts cannot be visualized, and subsequently not adequately reproduced using established imaging methods. This has made implementation in IOL power calculation difficult.

In everyday clinical practice, however, anterior segment OCT imaging devices are equipped with features that allow for an estimation of lens diameter. This is achieved by extrapolating the anterior and posterior curvature of the natural lens, which unfortunately makes this approach prone to error. Other imaging techniques, such as magnetic resonance imaging, are impractical in routine clinical practice due to time and cost considerations. However, they could be highly beneficial for future predictive approaches of the lens diameter The aim of this study is to develop a model for incorporating the lens diameter into IOL calculation. This will be achieved by using different imaging technologies to determine the actual lens diameter. The diameter will then be predicted using available biometric variables.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Cohort with MRI

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

Swept-Source Anterior Segment OCT

Intervention Type: 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 without MRI

Study cohort who doesn't receive an MRI

Swept-Source Anterior Segment OCT

Intervention Type: 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

Interventions

Swept-Source Anterior Segment OCT

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Kepler University of Linz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nino Hirnschall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

JKU Linz

Locations

Kepler University Clinic, Linz

Linz, , Austria

Countries

Austria

Central Contacts

Nino Hirnschall, MD PhD

Role: CONTACT

nino.hirnschall@kepleruniklinikum.at

0043(0)5768083 ext. 1056

Leon Pomberger, MD

Role: CONTACT

leon.pomberger@kepleruniklinikum.at

0043(0)5768083 ext. 1056

Facility Contacts

Nino Hirnschall, MD, PhD

Role: primary

nino.hirnschall@kepleruniklinikum.at

0043(0)5768083 ext. 1056

Leon Pomberger, MD

Role: backup

nino.hirnschall@kepleruniklinikum.at

0043(0)5768083 ext. 1056

Other Identifiers

KUK-Ophthalmology-015

Identifier Type: -

Identifier Source: org_study_id