Intraocular Lens Calculation Using Artificial Intelligence

Not yet recruiting

• Conditions: Cataract

• Registration Number: NCT07202767
• Lead Sponsor: Johannes Kepler University of Linz

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.

Study Timeline

• Study First Submitted: 2025-09-23
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-11-01
• Primary Completion: 2027-07-30
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	preoperatively, 4 and 12 weeks post cataract surgery	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).
Prediction model to estimate lens diameter with cerebral Magnetic Resonance Imaging	12 weeks post cataract surgery	Developing a prediction model to accurately estimate the lens diameter using cerebral Magnetic Resonance Imaging to examine ocular configuration

Secondary Outcome Measures

Name	Time	Method
IOL calculation concept an artificial intelligence approach	preoperatively, 4 and 12 weeks post cataract surgery	Development of a new IOL calculation concept which includes the lens diameter using an artificial intelligence approach
Different measurement modalities for the biometry of the eye	4 and 12 weeks post cataract surgery	Comparison of different measurement modalities (swept-source anterior segment Optical Coherence Topography; anterior segment-Optical Coherence Tomography and Placido topography with Optical Coherenece Topography-based anterior segment tomography; wave-front abberometry; swept-source Optical Coherence Tomography and optical biometer) for the biometry of the eye

Trial Locations

Locations (1)

Kepler University Clinic, Linz; 🇦🇹 Linz, Austria