CorVision® 4-year Follow-up

Primary outcomes

• Uncorrected Near Visual Acuity of 0.3 logMAR or better [At least 4 years after the implantation]: More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
• Implant removal [At least 4 years after the implantation]: The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.

Secondary outcomes

• Clinically significant corneal haze occurrence [At least 4 years after the implantation]: Clinically significant corneal haze is defined as any new stromal clouding in or near the laser-created pocket that leads to a reduction in central corneal clarity/transparency, is visible upon slit-lamp examination, and is graded as ≥ 2 on a standardized corneal haze grading scale.

Other outcomes

• Monocular Uncorrected Near Visual Acuity at Best Reading Distance [At least 4 years after the implantation]: Change in monocular uncorrected near visual acuity and best reading distance over time
• Monocular and Binocular Uncorrected Near Visual Acuity at 40 cm [At least 4 years after the implantation]: Change in monocular and binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm.
• Monocular and Binocular Distance Corrected Near Visual Acuity [At least 4 years after the implantation]: Change in monocular and binocular Distance Corrected Near Visual Acuity (DCNVA).
• Monocular and Binocular Corrected Near Visual Acuity [At least 4 years after the implantation]: Change in monocular and binocular Corrected Near Visual Acuity (CNVA) over time.
• Monocular and Binocular Uncorrected Intermediate Visual Acuity (UIVA) [At least 4 years after the implantation]: Change in monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) over time.
• Monocular and Binocular Distance Corrected Intermediate Visual Acuity [At least 4 years after the implantation]: Change in monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) over time.
• Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) [At least 4 years after the implantation]: Change in monocular Uncorrected Distance Visual Acuity (UDVA) over time.
• Monocular and Binocular Corrected Distance Visual Acuity (CDVA) [At least 4 years after the implantation]: Change in monocular and binocular Corrected Distance Visual Acuity (CDVA) over time.
• Objective refraction [At least 4 years after the implantation]: Change in objective refractive sphere and cylinder magnitude measured by autorefractometry.
• Subjective refraction [At least 4 years after the implantation]: Change in manifest refractive sphere and cylinder magnitude, measured in diopters (D).
• Near addition [At least 4 years after the implantation]: Change in near addition values over time.
• Corneal Keratometry Measurements (K1, K2, and Kmean) [At least 4 years after the implantation]: Change in corneal keratometry values, including K1, K2, and mean keratometry (Kmean), as measured by corneal topography over time. Change in keratometry K1, K2 and Kmean measured in diopters over time.
• Central Corneal Thickness (Pachymetry) Measurement [At least 4 years after the implantation]: Change in central corneal thickness as measured by corneal pachymetry over time.
• Endothelial Cell Density (Study Eye) [At least 4 years after the implantation]: Change in endothelial cell density over time.
• Intraocular Pressure (Study Eye) [At least 4 years after the implantation]: Change in intraocular pressure over time.
• Tear Film Break-Up Time (TBUT) Test [At least 4 years after the implantation]: Change in tear film stability as measured by Tear Film Break-Up Time (TBUT) in units of seconds.
• Tear Production (Schirmer Test) [At least 4 years after the implantation]: Change in tear production as measured by the Schirmer test in units of mm.
• Corneal Thickness Measurement Using Optical Coherence Tomography (OCT) [At least 4 years after the implantation]: Change in corneal thickness measured at the corneal center in μm.
• Abnormal findings at OCT [At least 4 years after the implantation]: Incidence of abnormal findings on OCT.
• Slit-lamp findings [At least 4 years after the implantation]: Incidence of abnormal slit lamp findings (eyelid, conjunctiva, epithelium, stroma, central cornea clarity, cornea neovascularization, anterior chamber, iris, lens).
• Contrast sensitivity [At least 4 years after the implantation]: Determination of contrast sensitivity measured by CSV 1000 (Vector Vision) (changes from the pre-operative to the post-operative state and its stability over time will be investigated).
• Defocus curve [At least 4 years after the implantation]: Change in visual acuity measured at different defocus vergence levels during monocular defocus curve testing over time.
• Aberrometry measurements using iTrace [At least 4 years after the implantation]: Change in the total higher order aberrations (HOA) assessed by iTrace.
• Subjective questionnaire QoV - patient satisfaction [At least 4 years after the implantation]: Evaluation of patient satisfaction assessed on a scale
• Subjective questionnaire QoV [At least 4 years after the implantation]: Evaluation of patient satisfaction as assessed using the Quality of Vision (QoV) questionnaire scoring scale.
• Adverse events incidence [At least 4 years after the implantation]: Intraoperative and adverse events at each time point (numbers and percentages)

Sex: All

Inclusion Criteria:

* Subjects must have undergone implantation of CorVision microlens under study protocol CMG-PRT-002.
* Provide informed consent
* Willing to participate in the ophthalmological examinations

Exclusion Criteria:

* Patients with severe ocular or general disorders that would prevent them from completed the visit.
* Patients not being able to understand and give informed consent.