CataractNCT05779319
1000 Eyes Lens Biometry Study: Artificial Intelligence for Intraocular Lens Power Calculation
An observational study of Cataract, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Cataract
- What is being tested?
- non contact measurement with the IOL Master 700
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will routinely undergo cataract surgery at one of the participating centers will be asked during the preliminary examination if they want to participate in the study. If they meet the inclusion criteria, they will be called to the clinic for a postoperative measurement within 4 weeks to 24 months after surgery.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Kepler University Klinik Departement of Opthalmology
Linz, Upperaustria, 4020
Leon U Pomberger, Dr., +496645891357, leon.pomberger@kepleruniklinikum.at
Nino U Hirnschall, Dr., nino.hirnschall@kepleruniklinikum.at
About this study
Official title: The 1000 Eyes Lens Power Trial: Introducing Artificial Intelligence to Intraocular Lens Power Calculation
The main purpose of the study is to develop an AI approach to improve intraocular lens power calculations.
Read the 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
- Being tested
- non contact measurement with the IOL Master 700
- Keywords
- lens power calculation, biometry, artificial inteligence
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non contact measurement with the IOL Master 700Device
postoerpative we will perform non contact measurement with the IOL Master 700
What is being measured
The primary outcome is the main question the study is designed to answer.
a new artificial intelligence based approach for intraocular lens power calculation
Developing an artificial intelligence algorithm to predict post-operative refraction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Feb 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Mein Hanusch-Krankenhaus, Medical University of Graz, Landesklinikum Sankt Polten
- Responsible party
- Sponsor
- Investigators
- Nino Hirnschall, MD, Principal investigator, JKU Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779319
- Sponsor's protocol ID
- KUK-Opthalmology-013
- Status last verified
- Oct 2023
- First submitted
- 9 Mar 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 1000 Eyes Lens Power Trial: Introducing Artificial Intelligence to Intraocular Lens Power Calculation
- ClinicalTrials.gov ID
- NCT05779319
- Acronym / sponsor ID
- KUK-Opthalmology-013
- Conditions
- Cataract
- Keywords
- lens power calculation, biometry, artificial inteligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Collaborators
- Mein Hanusch-Krankenhaus, Medical University of Graz, Landesklinikum Sankt Polten
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will routinely undergo cataract surgery at one of the participating centers will be asked during the preliminary examination if they want to participate in the study. If they meet the inclusion criteria, they will be called to the clinic for a postoperative measurement within 4 weeks to 24 months after surgery.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non contact measurement with the IOL Master 700postoerpative we will perform non contact measurement with the IOL Master 700 | Device | – |
Primary outcome
a new artificial intelligence based approach for intraocular lens power calculation
Time frame: 2 years
Developing an artificial intelligence algorithm to predict post-operative refraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nino Hirnschall, MD principal investigator
JKU Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nino Hirnschall, MD (+435768083 ext. 73411, nino.hirnschall@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a new artificial intelligence based approach for intraocular lens power calculation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.