Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography (PhysTilt)

October 3, 2023 updated by: Johannes Kepler University of Linz

Evaluation of the Physiological Crystalline Lens Tilt Using Longitudinal and High-resolution Swept-source Optical Coherence Tomography: a Retrospective Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The human (crystalline or phakic) lens is located in the capsular bag which is attached to zonules. Zonules are fibres, that hold the lens in place. In the course of life, an opacification on the lens occurs, which is called cataract. To replace the cloudy lens, cataract surgery is being performed and an artificial intraocular lens (IOL) is implanted in the eye, after the phakic lens is removed. Misalignment or tilting of IOLs can result in reduction of visual quality, therefore prediction of the position may be beneficial. Modern optical coherence tomography (OCT) devices already provide profound information about phakic lens tilt. Still there is little data on the values that influence the tilt of the crystalline lens. Before each cataract surgery, each eye is measured using biometry (IOL Master 700). However, a statement about the tilt cannot be made on the basis of the results of IOL Master 700. For this purpose, an anterior segment OCT is required (CASIA 2). In this study, preoperative biometry data are compared with anterior segment OCT data. A statistical analysis will then be performed to identify the biometric parameters that can predict phakic lens tilt.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Johannes Kepler University Linz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological lens tilt
Time Frame: June 2020 - October 2022
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of biometric data
Time Frame: June 2020 - October 2022
Correlation of other biometric data (lens thickness, anterior chamber depth, white-to-white) with lens tilt
June 2020 - October 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Kepler University of Linz

Investigators

  • Principal Investigator: Nino Hirnschall, MD, Johannes Kepler University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUK-Ophthalmology-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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