Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595693
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Tilt Prediction of Clareon Intraocular Lens
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measurement and Prediction of Tilt and Decentration of the Clareon Intraocular Lens and Evaluation of Its Effect of Visual Acuity
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Misalignment of intraocular lenses can cause severe loss of visual quality Different types of misalignments are known Tilt one type of intraocular lens misalignment is thought to play a negative role for the optical performance in eyes with intraocular designs especially if they have aspheric toric or multifocal optics Various methods to measure intraocular lens misalignments have been described 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 optical coherence tomography based devices are available in most clinics the resolution of modern optical coherence tomography devices is high and the measurements are reproducible
Detailed Description:
During cataract surgery an artificial intraocular lens is implanted in the eye to replace the lens and to correct the refraction for distance vision Misalignment of intraocular lenses can cause severe loss of visual quality Different types of misalignments are known Tilt one type of intraocular lens misalignment is thought to play a negative role for the optical performance in eyes with intraocular lens designs especially if they have aspheric toric or multifocal optics For example in the case of aspheric intraocular lenses 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 intraocular lenses In the case of toric intraocular lenses tilt introduces higher order aberrations potentially mimicking astigmatism In the case of multifocal intraocular lenses tilt increases higher order aberrations which leads to decreased visual quality
Various methods to measure intraocular lens misalignments have been described Studies assessing the intraocular lens position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess intraocular lens 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 intraocular lens 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 intraocular lens 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 intraocular lens 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 intraocular lenses Two different clinically applicable Purkinjemeter system provide the measurement of intraocular 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 optical coherence tomography based devices are available in most clinics the resolution of modern optical coherence tomography devices is high and the measurements are reproducible
Various methods to measure intraocular lens misalignments have been described Studies assessing the intraocular lens position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess intraocular lens 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 intraocular lens 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 intraocular lens 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 intraocular lens 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 intraocular lenses Two different clinically applicable Purkinjemeter system provide the measurement of intraocular 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 optical coherence tomography based devices are available in most clinics the resolution of modern optical coherence tomography devices is high and the measurements are reproducible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None