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The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.
Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 640PM implanted | Patients implanted binocularly with Medicontur's intraocular lens model 640PM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular lens | Device | Aspheric hydrophilic acrylic IOL for implantation into the capsular bag |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corrected distance visual acuity (CDVA); | 12 months after IOL implantation |
| Measure | Description | Time Frame |
|---|---|---|
| visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA) | 1 and 12 months after IOL implantation; | |
| Manifest spherical equivalent refraction (SEQ) | 3 and 12 months after IOL implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary surgical intervention rate | 12 months after IOL implantation; | |
| Collect and evaluate ocurrence of adverse events detected | from surgery to 12 months after IOL implantation | |
Inclusion Criteria:
Exclusion Criteria:
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Adults (18 years old and older) with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia, who has binocular 640PM IOL implantation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vithas AlmerÃa | AlmerÃa | 04120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37464551 | Derived | Fernandez J, Srinivasan S, Burguera N, Martinez J, Rodriguez-Vallejo M. One-year follow-up of a multifocal intraocular lens with optimized elevated phase shift. J Cataract Refract Surg. 2023 Oct 1;49(10):1018-1024. doi: 10.1097/j.jcrs.0000000000001266. |
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| VADC (monocular with best distance correction) under photopic conditions | 3 months after IOL implantation |
| CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions | 3 months after IOL implantation; |
| CSDC (binocular without best distance correction) under photopic and mesopic conditions | 12 months after IOL implantation; |
| Visual Function by VF-14 | 12 months after IOL implantation; |
| Patient satisfaction self-reported by the participant | 12 months after IOL implantation |
| Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant | 12 months after IOL implantation |
| spectacle independence self-reported by the participant | 12 months after IOL implantation |
| PCO rate |
| 12 months after IOL implantation |
| Nd-YAG capsulotomy rate | 12 months after IOL implantation |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| D006956 | Hyperopia |
| D009216 | Myopia |
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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