1000 Eyes Lens Biometry Study: Artificial Intelligence for Intraocular Lens Power Calculation

Cataract Clinical Trial

Official title:

The 1000 Eyes Lens Power Trial: Introducing Artificial Intelligence to Intraocular Lens Power Calculation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779319
• Other study ID #: KUK-Opthalmology-013
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: Johannes Kepler University of Linz
• Contact: Nino Hirnschall, MD
• Phone: +435768083
• Email: nino.hirnschall[@]kepleruniklinikum.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations.

Description:

Cataract surgery is one of the most commonly performed surgeries worldwide and has a high postoperative patient satisfaction rate. Despite significant improvement in measurement methods and artificial lens power calculation formulas, miscalculations and subsequently refractive error still occur after cataract surgery.

Most current artificial lens calculation methods use regression formulas. The concept of artificial intelligence (AI) has only recently found use and only in a rudimentary way. Examples include the Hill-RBF calculator and the Ladas superformula, but at least the "superformula" does not use a true AI approach and the results are no better than those obtained with conventional methods.

The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations. The data will be used for the following analysis:

• To compare the new AI method with conventional and modern formula (main question)

• To compare the refractive error for different eye lengths

• To use a ray tracing method to quantify sources of error in patients with a refractive surprise of at least 1.0 diopter

• To evaluate a novel concept of outlier testing using a modified nonparametric Walsh test

This study will be multi-center and partially prospective. Data from 1000 patients who have already had cataract surgery will be analyzed.

All patients will be invited for a visit to the recruitment clinic and the measurements will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 110 Years

Eligibility

Inclusion Criteria:

• Pseudophakic (at least one eye): cataract surgery between 4 weeks and 24 months prior to recruitment

• If both eyes would be suitable for the study only the right eye will be included, if only one eye is suitable for the study, this eye will be included

• Pre-operative swept-source OCT biometry available (no ultrasound measurement for axial eye length)

• Uncomplicated cataract surgery

• Age 21 years and older

Exclusion Criteria:

• Multifocal IOLs

• Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)

• Best corrected distance visual acuity below 0.5 Snellen

• In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• non contact measurement with the IOL Master 700
postoerpative we will perform non contact measurement with the IOL Master 700

Locations

Country	Name	City	State
Austria	Kepler University Klinik Departement of Opthalmology	Linz	Upperaustria

Sponsors (4)

Lead Sponsor	Collaborator
Johannes Kepler University of Linz	Landesklinikum Sankt Polten, Medical University of Graz, Mein Hanusch-Krankenhaus

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a new artificial intelligence based approach for intraocular lens power calculation	Developing an artificial intelligence algorithm to predict post-operative refraction	2 years