NCT05779319

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

March 9, 2023

Last Update Submit

October 3, 2023

Conditions

Cataract

Keywords

lens power calculationbiometryartificial inteligence

Outcome Measures

Primary Outcomes (1)

  • a new artificial intelligence based approach for intraocular lens power calculation

    Developing an artificial intelligence algorithm to predict post-operative refraction

    2 years

Interventions

non contact measurement with the IOL Master 700DEVICE

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

Eligibility Criteria

Age21 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Klinik Departement of Opthalmology

Linz, Upperaustria, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Nino Hirnschall, MD

    JKU Linz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nino Hirnschall, MD

CONTACT

+435768083nino.hirnschall@kepleruniklinikum.at

Matthias Bolz, MD

CONTACT

+435768083matthias.bolz@kepleruniklinikum.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

February 1, 2022

Primary Completion

July 30, 2024

Study Completion

September 30, 2025

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

AU(1)