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This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL Implantation | Experimental | Implantation of IOL: PhysIOL POD F GF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of IOL: PhysIOL POD F GF | Device | Implantation of trifocal IOL POD F GF consisting of hydrophobic material |
|
| Measure | Description | Time Frame |
|---|---|---|
| binocular Distance Corrected Near Visual Acuity (DCNVA) | measured in logMAR | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| monocular and binocular Uncorrected Distance Visual Acuity (UDVA) | measured in logMAR | 3 months postoperative |
| monocular and binocular Corrected Distance Visual Acuity (CDVA) | measured in logMAR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uday Bhatt, MD | Vision Eye Institute - Footscray | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Eye Institute | Footscray | Victoria | 3011 | Australia |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 3 months postoperative |
| monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) | measured in logMAR | 3 months postoperative |
| monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | measured in logMAR | 3 months postoperative |
| monocular and binocular Uncorrected Near Visual Acuity (UNVA) | measured in logMAR | 3 months postoperative |
| monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) | measured in logMAR | 3 months postoperative |
| Contrast Sensitivity (mesopic and photopic) | measured in logCS | 3 months postoperative |