Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography (PhysTilt)
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| ClinicalTrials.gov Identifier: NCT05690893 |
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Recruitment Status :
Not yet recruiting
First Posted : January 19, 2023
Last Update Posted : January 19, 2023
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Sponsor:
Johannes Kepler University of Linz
Information provided by (Responsible Party):
Johannes Kepler University of Linz
| Tracking Information | |||||||||
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| First Submitted Date | January 10, 2023 | ||||||||
| First Posted Date | January 19, 2023 | ||||||||
| Last Update Posted Date | January 19, 2023 | ||||||||
| Estimated Study Start Date | February 1, 2023 | ||||||||
| Estimated Primary Completion Date | March 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Crystalline Lens Tilt Evaluation Using Swept-source Optical Coherence Tomography | ||||||||
| Official Title | Evaluation of the Physiological Crystalline Lens Tilt Using Longitudinal and High-resolution Swept-source Optical Coherence Tomography: a Retrospective Study | ||||||||
| 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. | ||||||||
| 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 Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients between 21 and 100 years who received preliminary examinations as part of cataract surgery | ||||||||
| Condition | Cataract Surgery | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 30, 2023 | ||||||||
| Estimated Primary Completion Date | March 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 21 Years to 100 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05690893 | ||||||||
| Other Study ID Numbers | KUK-Ophthalmology-010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Johannes Kepler University of Linz | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Johannes Kepler University of Linz | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Johannes Kepler University of Linz | ||||||||
| Verification Date | January 2023 | ||||||||