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

Sponsor

Johannes Kepler University of Linz (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05690893

Collaborator

(none)

1,000

Enrollment

4.9

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated 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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Outcome Measures

Primary Outcome Measures

Physiological lens tilt [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

Correlation of biometric data [June 2020 - October 2022]
Correlation of other biometric data (lens thickness, anterior chamber depth, white-to-white) with lens tilt

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Johannes Kepler University of Linz

Investigators

Principal Investigator: Nino Hirnschall, MD, Johannes Kepler University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johannes Kepler University of Linz

ClinicalTrials.gov Identifier:

NCT05690893

Other Study ID Numbers:

KUK-Ophthalmology-010

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Johannes Kepler University of Linz

Cataract, CASIA2, IOL Master700

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jan 19, 2023