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OpenTrials
Completed

NCT Number: NCT05690893

Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography

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.

Completed

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johannes Kepler University Linz

Linz, Upper Austria, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Registry information

Official study title

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

Acronym: PhysTilt

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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