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Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted.
Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak & Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.
Main objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation | Experimental | PhysIOL POD F GF: 50 (bilateral implantation) PhysIOL POD F: 50 (bilateral implantation) Alcon PanOptix: 20 (bilateral implantation) In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation | Device | In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Best corrected distance visual acuity (5 m) | CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014. | Postoperative Day 75-105 (3 months) |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gerd Auffarth, MD, PhD | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augenklinik Ahaus | Ahaus | 48683 | Germany | |||
| Internationale Innovative Ophthalmochirgie |
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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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Study procedure guidelines
Patients who were previously treated with a premium IOL (Panoptix, POD FGF, POD F) are continuously included:
Retrospective:
Routine data collected up to the first study visit (preoperative, intraoperative and postoperative) are evaluated retrospectively
Prospective:
2-4 months postoperatively: refraction and vision, slit lamp and fundus examination, intraocular
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| Düsseldorf |
| 40212 |
| Germany |
| Universitäts-Augenklinik Heidelberg | Heidelberg | 69120 | Germany |
| Augentagesklinik Rheine | Rheine | 48429 | Germany |