Cataract SurgeryPhysTiltNCT05690893
Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography
An observational study of Cataract Surgery, run by Johannes Kepler University of Linz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cataract Surgery
- How many people
- 1,000 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between 21 and 100 years who received preliminary examinations as part of cataract surgery
Who may be able to join
- Planned cataract surgery in one or both eyes
- Minimum age of 21 years
Who cannot join
- Opacities of the refracting media
- Measurement error in the context of preliminary investigation
- pseudophakia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract Surgery
- Keywords
- Cataract, CASIA2, IOL Master700
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: June 2020 - October 2022
Secondary outcomes (1)
Correlation of biometric data
Correlation of other biometric data (lens thickness, anterior chamber depth, white-to-white) with lens tilt
Measured: June 2020 - October 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nino Hirnschall, MD, Principal investigator, Johannes Kepler University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690893
- Sponsor's protocol ID
- KUK-Ophthalmology-010
- Acronym
- PhysTilt
- Status last verified
- Oct 2023
- First submitted
- 10 Jan 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Physiological Crystalline Lens Tilt Using Longitudinal and High-resolution Swept-source Optical Coherence Tomography: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05690893
- Acronym / sponsor ID
- PhysTilt / KUK-Ophthalmology-010
- Conditions
- Cataract Surgery
- Keywords
- Cataract, CASIA2, IOL Master700
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 21 and 100 years who received preliminary examinations as part of cataract surgery
Key inclusion criteria (2 listed)
- Planned cataract surgery in one or both eyes
- Minimum age of 21 years
Key exclusion criteria (3 listed)
- Opacities of the refracting media
- Measurement error in the context of preliminary investigation
- pseudophakia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Correlation of biometric data
Time frame: June 2020 - October 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nino Hirnschall, MD principal investigator
Johannes Kepler University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Surgery, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological lens tilt (time frame: June 2020 - October 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.