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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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The study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo & Glare Simulator.
The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINI WELL Ready (SIFI SpA, Italy) | Extended depth of focus intraocular lens implantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINI WELL Ready (SIFI SpA, Italy) | Device | Implantation during cataract surgery of the progressive extended depth of focus intraocular lens for the posterior chamber to replace the crystalline lens in the correction of aphakia in adult patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Refraction | 26 months | |
| Binocular Defocus Curve | Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments) | 26 months |
| UDVA | Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m | 26 months |
| CDVA | Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m | 26 months |
| UIVA at 100 cm | Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast) | 26 months |
| DCIVA at 100 cm | Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast) | 26 months |
| UIVA at 60 cm | Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast) | 26 months |
| DCIVA at 60 cm | Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast) | 26 months |
| UNVA |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications Rate of postoperative complication | 26 months | |
| Subjective Posterior Capsule Opacification | Subjective assessment through slit lamp | 20-26 months |
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Inclusion Criteria:
• Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:
Exclusion Criteria:
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Subjects affected by cataract that fulfill eligibility criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro" | Bari | 70121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22553713 | Result | Jiang T, Jiang J, Zhou Y, Zhao GQ, Li H, Zhao SY. Cataract surgery in aged patients: phacoemulsification or small-incision extracapsular cataract surgery. Int J Ophthalmol. 2011;4(5):513-8. doi: 10.3980/j.issn.2222-3959.2011.05.11. Epub 2011 Oct 18. | |
| 18090888 | Result | Packer M, Fine IH, Hoffman RS. Aspheric intraocular lens selection: the evolution of refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):1-4. doi: 10.1097/ICU.0b013e3282f2d791. No abstract available. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast) |
| 26 months |
| DCNVA | Monocular and Binocular Distance Corrected Near Visual Acuity at 40cm (100% contrast) | 26 months |
| Contrast Sensitivity | Binocular Contrast Sensitivity with correction for distance | 26 months |
| Reading Performance | Binocular Reading Performance with and without correction for distance | 26 months |
| VR-11R | Visual Function -11R Questionnaire from 4 (without difficulties) to 0 (performance impossible due to difficulties) | 26 months |
| Posterior Capsulotomy | 26 months |
| Adverse Events including SSIs | 26 months |
| Device Deficiencies | Descriptive assessment | 26 months |
| Photic Phenomena Assessment | Using the Halo and Glare Simulator software | 26 months |
| 19643497 | Result | Kohnen T, Klaproth OK, Buhren J. Effect of intraocular lens asphericity on quality of vision after cataract removal: an intraindividual comparison. Ophthalmology. 2009 Sep;116(9):1697-706. doi: 10.1016/j.ophtha.2009.03.052. Epub 2009 Jul 29. |
| 16687454 | Result | Becker KA, Martin M, Rabsilber TM, Entz BB, Reuland AJ, Auffarth GU. Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study. Br J Ophthalmol. 2006 Aug;90(8):971-4. doi: 10.1136/bjo.2006.092437. Epub 2006 May 10. |
| 17166341 | Result | Lehmann R, Waycaster C, Hileman K. A comparison of patient-reported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens. Curr Med Res Opin. 2006 Dec;22(12):2591-602. doi: 10.1185/030079906X158039. |
| 13129879 | Result | Leyland M, Zinicola E. Multifocal versus monofocal intraocular lenses in cataract surgery: a systematic review. Ophthalmology. 2003 Sep;110(9):1789-98. doi: 10.1016/S0161-6420(03)00722-X. |
| 10724823 | Result | Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004. |
| 16931257 | Result | Blaylock JF, Si Z, Vickers C. Visual and refractive status at different focal distances after implantation of the ReSTOR multifocal intraocular lens. J Cataract Refract Surg. 2006 Sep;32(9):1464-73. doi: 10.1016/j.jcrs.2006.04.011. |
| 42376480 | Derived | Sborgia A, Curatolo MC, Barattini DF, Niro A, Barattini L, Sborgia G. Two-Year Follow-Up of the MINI WELL Non-Diffractive Extended Depth-of-Focus Intraocular Lens: A Retrospective Observational Study. Clin Ophthalmol. 2026 Jun 24;20:602800. doi: 10.2147/OPTH.S602800. eCollection 2026. |