NCT05690893

Brief Summary

The goal of this retrospective study is to quantify the physiological lens tilt of the phakic eye. The main question it aims to answer is:

  • What influence does misalignment or tilting of IOLs have on visual quality? Preoperative biometry data are compared with anterior segement OCT data. Measurements were obtained using high-resolution swept-source optical coherence tomography. The influence of biometric measurements on tilt is analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

January 10, 2023

Last Update Submit

October 3, 2023

Conditions

Cataract Surgery

Keywords

CataractCASIA2IOL Master700

Outcome Measures

Primary Outcomes (1)

  • Physiological lens tilt

    SS-OCT measurements (IOLMaster700 and Casia2) to investigate axial eye length, anterior chamber depth and lens thickness and their influence on lens tilt

    June 2020 - October 2022

Secondary Outcomes (1)

  • Correlation of biometric data

    June 2020 - October 2022

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between 21 and 100 years who received preliminary examinations as part of cataract surgery

You may qualify if:

  • Planned cataract surgery in one or both eyes
  • Minimum age of 21 years

You may not qualify if:

  • Opacities of the refracting media
  • Measurement error in the context of preliminary investigation
  • pseudophakia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Kepler University Linz

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Nino Hirnschall, MD

    Johannes Kepler University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

February 1, 2023

Primary Completion

March 30, 2023

Study Completion

June 30, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations

AU(1)