Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment. Approximately 100 patients in the Czech Republic will participate in this study. The study was reviewed and approved by an independent research ethics committee and also by the State Institute for Drug Control (SÚKL). The study will consist of a single visit during which standard, non-invasive, and painless examinations will be performed. This visit will correspond to the 4-year follow-up visit of the original clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-presbyopia correction with unilaterally implanted microlens | Presbyopic patients who have undergone implantation of the CorVision microlens according to study protocol CMG-PRT-002. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Near Visual Acuity of 0.3 logMAR or better | More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively. | At least 4 years after the implantation |
| Implant removal | The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes. | At least 4 years after the implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant corneal haze occurrence | 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. | At least 4 years after the implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Uncorrected Near Visual Acuity at Best Reading Distance | Change in monocular uncorrected near visual acuity and best reading distance over time | At least 4 years after the implantation |
| Monocular and Binocular Uncorrected Near Visual Acuity at 40 cm |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
The target population are patients who suffered from presbyopia and underwent the original CorVision clinical study are medically suitable to undertake the current clinical study investigation.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemini Eye Clinic | Zlín | 760 01 | Czechia |
Not provided
| Label | URL |
|---|---|
| the protocol of the original study - ClinicalTrials.gov ID: NCT04465409 | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Change in monocular and binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm. |
| At least 4 years after the implantation |
| Monocular and Binocular Distance Corrected Near Visual Acuity | Change in monocular and binocular Distance Corrected Near Visual Acuity (DCNVA). | At least 4 years after the implantation |
| Monocular and Binocular Corrected Near Visual Acuity | Change in monocular and binocular Corrected Near Visual Acuity (CNVA) over time. | At least 4 years after the implantation |
| Monocular and Binocular Uncorrected Intermediate Visual Acuity (UIVA) | Change in monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) over time. | At least 4 years after the implantation |
| Monocular and Binocular Distance Corrected Intermediate Visual Acuity | Change in monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) over time. | At least 4 years after the implantation |
| Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) | Change in monocular Uncorrected Distance Visual Acuity (UDVA) over time. | At least 4 years after the implantation |
| Monocular and Binocular Corrected Distance Visual Acuity (CDVA) | Change in monocular and binocular Corrected Distance Visual Acuity (CDVA) over time. | At least 4 years after the implantation |
| Objective refraction | Change in objective refractive sphere and cylinder magnitude measured by autorefractometry. | At least 4 years after the implantation |
| Subjective refraction | Change in manifest refractive sphere and cylinder magnitude, measured in diopters (D). | At least 4 years after the implantation |
| Near addition | Change in near addition values over time. | At least 4 years after the implantation |
| Corneal Keratometry Measurements (K1, K2, and Kmean) | 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. | At least 4 years after the implantation |
| Central Corneal Thickness (Pachymetry) Measurement | Change in central corneal thickness as measured by corneal pachymetry over time. | At least 4 years after the implantation |
| Endothelial Cell Density (Study Eye) | Change in endothelial cell density over time. | At least 4 years after the implantation |
| Intraocular Pressure (Study Eye) | Change in intraocular pressure over time. | At least 4 years after the implantation |
| Tear Film Break-Up Time (TBUT) Test | Change in tear film stability as measured by Tear Film Break-Up Time (TBUT) in units of seconds. | At least 4 years after the implantation |
| Tear Production (Schirmer Test) | Change in tear production as measured by the Schirmer test in units of mm. | At least 4 years after the implantation |
| Corneal Thickness Measurement Using Optical Coherence Tomography (OCT) | Change in corneal thickness measured at the corneal center in μm. | At least 4 years after the implantation |
| Abnormal findings at OCT | Incidence of abnormal findings on OCT. | At least 4 years after the implantation |
| Slit-lamp findings | Incidence of abnormal slit lamp findings (eyelid, conjunctiva, epithelium, stroma, central cornea clarity, cornea neovascularization, anterior chamber, iris, lens). | At least 4 years after the implantation |
| Contrast sensitivity | 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). | At least 4 years after the implantation |
| Defocus curve | Change in visual acuity measured at different defocus vergence levels during monocular defocus curve testing over time. | At least 4 years after the implantation |
| Aberrometry measurements using iTrace | Change in the total higher order aberrations (HOA) assessed by iTrace. | At least 4 years after the implantation |
| Subjective questionnaire QoV - patient satisfaction | Evaluation of patient satisfaction assessed on a scale | At least 4 years after the implantation |
| Subjective questionnaire QoV | Evaluation of patient satisfaction as assessed using the Quality of Vision (QoV) questionnaire scoring scale. | At least 4 years after the implantation |
| Adverse events incidence | Intraoperative and adverse events at each time point (numbers and percentages) | At least 4 years after the implantation |