Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography

Cataract Surgery Clinical Trial

— PhysTilt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690893
• Other study ID #: KUK-Ophthalmology-010
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Johannes Kepler University of Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Locations

Country	Name	City	State
Austria	Johannes Kepler University Linz	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Kepler University of Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of biometric data	Correlation of other biometric data (lens thickness, anterior chamber depth, white-to-white) with lens tilt	June 2020 - October 2022