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

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ClinicalTrials.gov Identifier: NCT05690893
Recruitment Status : Not yet recruiting
First Posted : January 19, 2023
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Johannes Kepler University of Linz

Study Description
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Brief Summary:
This retrospective epidemiological study aims to quantify the physiological lens tilt of the phakic eye. Measurements were obtained using high-resolution swept-source optical coherence tomography. The influence of biometric measurements on tilt is analyzed.

Condition or disease
Cataract Surgery

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 with this device. For this purpose, an anterior segment OCT is required (CASIA 2). In our 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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Physiological Crystalline Lens Tilt Using Longitudinal and High-resolution Swept-source Optical Coherence Tomography: a Retrospective Study
Estimated Study Start Date : February 1, 2023
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05690893


Contacts
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Contact: Nino Hirnschall, MD 00437327806 ext 1510 nino.hirnschall@kepleruniklinikum.at
Contact: Haidar Khalil, MD 00437327806 ext 1510 haidar.khalil@kepleruniklinikum.at

Sponsors and Collaborators
Johannes Kepler University of Linz
Investigators
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Principal Investigator: Nino Hirnschall, MD Johannes Kepler University
More Information
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Responsible Party: Johannes Kepler University of Linz
ClinicalTrials.gov Identifier: NCT05690893    
Other Study ID Numbers: KUK-Ophthalmology-010
First Posted: January 19, 2023    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johannes Kepler University of Linz:
Cataract, CASIA2, IOL Master700
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases