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

NCT ID: NCT05779319

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2025-09-30

Brief Summary

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

Detailed 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.

Conditions

Cataract

Study Design

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

Interventions

non contact measurement with the IOL Master 700

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mein Hanusch-Krankenhaus

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: collaborator

Landesklinikum Sankt Polten

OTHER

Sponsor Role: collaborator

Johannes Kepler University of Linz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nino Hirnschall, MD

Role: PRINCIPAL_INVESTIGATOR

JKU Linz

Locations

Kepler University Klinik Departement of Opthalmology

Linz, Upperaustria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Nino Hirnschall, MD

Role: CONTACT

nino.hirnschall@kepleruniklinikum.at

+435768083 ext. 73411

Matthias Bolz, MD

Role: CONTACT

matthias.bolz@kepleruniklinikum.at

+435768083 ext. 78409

Facility Contacts

Leon U Pomberger, Dr.

Role: primary

leon.pomberger@kepleruniklinikum.at

+496645891357

Nino U Hirnschall, Dr.

Role: backup

nino.hirnschall@kepleruniklinikum.at

Other Identifiers

KUK-Opthalmology-013

Identifier Type: -

Identifier Source: org_study_id