The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
The device under investigation is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens indicated for aphakia after surgical extraction of the cataractous natural lens and is also indicated for the correction of regular corneal astigmatism.
Oční klinikaO
Prague, Prague, Czechia
RECRUITINGOční Centrum Praha
Prague, Czechia
RECRUITINGUniversitätsklinikum Heidelberg
Heidelberg, Germany
Refractive predictability
Difference between predicted Manifest Refraction Spherical Equivalent and achieved Manifest Refraction Spherical Equivalent at the final postoperative visit: Percentage of first implanted eyes within ± 1.0 D
Time frame: From preoperative visit to the final postoperative visit at twelve months
Refractive outcomes
Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent
Time frame: From preoperative visit to the final postoperative visit at twelve months
Refractive predictability
Percentage of eyes within ± 0.25 D, ± 0.5 D, \& ± 1.0 D
Time frame: From preoperative visit to the final postoperative visit at twelve months
Reduction in cylindrical power
The change in manifest refractive cylinder from baseline to the final postoperative visit.
Time frame: From preoperative visit to the final postoperative visit at twelve months
IOL Rotation
Percentage of IOLs with IOL rotation with less than 10 and 20 degrees.
Time frame: From preoperative visit to the final postoperative visit at twelve months
Stability of IOL axis orientation
Expressed as percentage of IOLs that rotate ≤ +/- 5 degrees postoperatively
Time frame: Between 30 to 60 days and 120 to 180 days
Axis Misalignment
The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PVK Precise Vision GmbH
Rheine, Germany
NOT_YET_RECRUITINGOfatlivist Alicante
Alicante, Spain
RECRUITINGAyrshire Eye Clinic
Ayr, Ayrshire, United Kingdom
NOT_YET_RECRUITINGTime frame: From baseline to postoperative visit 120-180 days
Monocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 12-Month Postoperative
Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better
Time frame: 12-Months Postoperatively
Monocular Best-Corrected Distance Visual Acuity (CDVA)
Time frame: 12-Months Postoperatively
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 12-Months Postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 12-Months Postoperatively
Monocular (1st eye implantations) defocus curve
Time frame: 12-Months Postoperatively
Binocular defocus curve on subjects implanted binocularly
Time frame: 12-Months Postoperatively
Intraocular Pressure
Time frame: 12-Months Postoperatively
Assessment of subject satisfaction, patient reported outcomes, and spectacle independence
Time frame: 12-Months Postoperatively
IOL observations
IOL Decentration, Tilt, Discoloration, Opacity, Glistenings
Time frame: 12-Months Postoperatively