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The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.
Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Bilateral implantation with PRECIZON Presbyopic intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRECIZON Presbyopic | Device | Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in monocular and binocular uncorrected and corrected near visual acuity | The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide near visual acuity | 3 months follow-up postoperative |
| Improvement in monocular and binocular uncorrected and corrected intermediate visual acuity | The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide intermediate visual acuity | 3 months post-op |
| Improvement in monocular and binocular uncorrected and corrected distance visual acuity | The ability of the PRECIZON Presbyopia Intraocular lens (IOL) to provide distance visual acuity | 3 months post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Photopic contrast sensitivity as measured by a contrast sensitivity chart | Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd. | 3 months postoperative |
| Mesopic contrast sensitivity as measured by a contrast sensitivity chart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike P. Holzer, Prof. Dr. | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipolis | Wilrijk | 2610 | Belgium | |||
| Universitäts-Augenklinik Heidelberg |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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|
Binocular contrast sensitivity scores for spatial frequencies of 3.0 cpd, 6.0 cpd, 12.0 cpd and 18.0 cpd. |
| 3 months post-op |
| Stability of manifest refraction (MRSE) as measured by a mean change in MRSE between visits as determined by a paired analysis | Percentage of eyes that achieve a change of less than or equal to 1.00 D of MRSE between two refractions performed 3 months apart | 3 months post-op |
| Spectacle dependency | Percentage of patients that achieve complete spectacle independence or occasional use of glasses for near or intermediate vision | 3 months post-op |
| Defocus curve | Binocular defocus evaluation will be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 D increments to -0.5 D. | 3 months post-op |
| Rates of adverse events and complications | 3 months post-op |
| Patient satisfaction as measured by a patient satisfaction questionnaire | 3 months post-op |
| Quality of vision as measured by the Quality of Vision (QoV) questionnaire | Percentage of patients with a QoV score >10 and >30 at 3 months postoperative | 3 months post-op |
| Heidelberg |
| 69120 |
| Germany |
| Academisch Ziekenhuis Maastricht | Maastricht | Limburg | 6229 HX | Netherlands |
| Oftalvist CIO Jerez | Jerez de la Frontera | 11408 | Spain |
| Hospital Universitari Mútua Terrassa | Terrassa | 08221 | Spain |
| Acibadem Maslak Hospital | Istanbul | 34457 | Turkey (Türkiye) |