Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305338
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2023-03-09
Brief Title:
Predicting Intraocular Lens Tilt Using OCT Measurements and Partial Least Squares Regression Modelling
Sponsor:
Johannes Kepler University of Linz
Organization:
Johannes Kepler University of Linz
Study Overview
Official Title:
Predicting Post-operative Intraocular Lens Tilt Using Optical Coherence Tomography Measurements and Partial Least Squares Regression Modelling
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tilt
Brief Summary:
During cataract surgery an artificial intraocular lens IOL is implanted in the eye to replace the lens and to correct the refraction for distance vision Misalignment of IOLs can cause severe loss of visual quality Different types of misalignment are known Tilt one type of IOL misalignment is thought to play a negative role for the optical performance in eyes with IOL designs especially if they have aspheric toric or multifocal optics
Various methods to measure IOL misalignments have been described Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt The subjective grading at the slitlamp may display considerable variability between examiners This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt The fact that the patient has no standardized target to focus on makes the method even less reliable Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position Additionally it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference Scheimpflug camera images have been used for assessing IOL tilt previously but erroneous results often due to corneal magnification have diminished their widespread use Another possibility to assess tilt is the use of Purkinje reflexes The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized Since light is reflected at all interfaces of media with a difference in refractive index these reflections called Purkinje images can be used to assess tilt and decentration of IOLs Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt The main problem with Purkinje meters is accessibility as there are only a few prototypes available worldwide
The most recently developed method for tilt quantification is the use of optical coherence tomography This method has several advantages compared to the previous methods OCT based devices are available in most clinics the resolution of modern OCT devices is high and the measurements are reproducible
Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression This method was developed by Wold and introduced to ophthalmology previously
Various methods to measure IOL misalignments have been described Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt The subjective grading at the slitlamp may display considerable variability between examiners This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt The fact that the patient has no standardized target to focus on makes the method even less reliable Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position Additionally it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference Scheimpflug camera images have been used for assessing IOL tilt previously but erroneous results often due to corneal magnification have diminished their widespread use Another possibility to assess tilt is the use of Purkinje reflexes The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized Since light is reflected at all interfaces of media with a difference in refractive index these reflections called Purkinje images can be used to assess tilt and decentration of IOLs Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt The main problem with Purkinje meters is accessibility as there are only a few prototypes available worldwide
The most recently developed method for tilt quantification is the use of optical coherence tomography This method has several advantages compared to the previous methods OCT based devices are available in most clinics the resolution of modern OCT devices is high and the measurements are reproducible
Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression This method was developed by Wold and introduced to ophthalmology previously
Detailed Description:
During cataract surgery an artificial intraocular lens IOL is implanted in the eye to replace the lens and to correct the refraction for distance vision Misalignment of IOLs can cause severe loss of visual quality Different types of misalignment are known Tilt one type of IOL misalignment is thought to play a negative role for the optical performance in eyes with IOL designs especially if they have aspheric toric or multifocal optics For example in the case of aspheric IOLs it appears that even slight amount of tilt may result not only in the loss of the effect of reducing spherical aberrations but in more severe cases even a worsening of the optical quality compared to spherical IOLs In the case of toric IOLs tilt introduces higher order aberrations potentially mimicking astigmatism In the case of multifocal IOLs tilt increases higher order aberrations which leads to decreased visual quality
Various methods to measure IOL misalignments have been described Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt The subjective grading at the slitlamp may display considerable variability between examiners This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt The fact that the patient has no standardized target to focus on makes the method even less reliable Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position Additionally it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference Scheimpflug camera images have been used for assessing IOL tilt previously but erroneous results often due to corneal magnification have diminished their widespread use Another possibility to assess tilt is the use of Purkinje reflexes The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized Since light is reflected at all interfaces of media with a difference in refractive index these reflections called Purkinje images can be used to assess tilt and decentration of IOLs Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt The main problem with Purkinje meters is accessibility as there are only a few prototypes available worldwide
The most recently developed method for tilt quantification is the use of optical coherence tomography This method has several advantages compared to the previous methods OCT based devices are available in most clinics the resolution of modern OCT devices is high and the measurements are reproducible
Due to the fact that tilt has an influence on visual quality the prediction of the post-operative tilt could improve IOL power calculation significantly especially for toric IOLs In the literature the prediction of tilt was shown to be acceptable for the orientation of tilt but not for the amount of tilt Furthermore there is disagreement concerning the fact if the amount of tilt increases or decreases after cataract surgery
Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression This method was developed by Wold and introduced to ophthalmology previously
Various methods to measure IOL misalignments have been described Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt The subjective grading at the slitlamp may display considerable variability between examiners This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt The fact that the patient has no standardized target to focus on makes the method even less reliable Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position Additionally it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference Scheimpflug camera images have been used for assessing IOL tilt previously but erroneous results often due to corneal magnification have diminished their widespread use Another possibility to assess tilt is the use of Purkinje reflexes The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized Since light is reflected at all interfaces of media with a difference in refractive index these reflections called Purkinje images can be used to assess tilt and decentration of IOLs Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt The main problem with Purkinje meters is accessibility as there are only a few prototypes available worldwide
The most recently developed method for tilt quantification is the use of optical coherence tomography This method has several advantages compared to the previous methods OCT based devices are available in most clinics the resolution of modern OCT devices is high and the measurements are reproducible
Due to the fact that tilt has an influence on visual quality the prediction of the post-operative tilt could improve IOL power calculation significantly especially for toric IOLs In the literature the prediction of tilt was shown to be acceptable for the orientation of tilt but not for the amount of tilt Furthermore there is disagreement concerning the fact if the amount of tilt increases or decreases after cataract surgery
Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression This method was developed by Wold and introduced to ophthalmology previously
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None