Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant
Sponsor study identifier
observational
23
1 country
1
Study Start
October 26, 2020
Actual (reported)Primary Completion
November 19, 2020
Actual (reported)Study Completion
November 19, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 19, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2020
Actual (reported)November 19, 2020
Actual (reported)November 19, 2020
Actual (reported)March 15, 2021
Actual (reported)March 17, 2021
Actual (reported)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)
Postoperative Complications Rate of postoperative complication
26 months
Subjective Posterior Capsule Opacification
20-26 months
Posterior Capsulotomy
26 months
Adverse Events including SSIs
26 months
Device Deficiencies
26 months
Extended depth of focus intraocular lens implantation
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects affected by cataract that fulfill eligibility criteria
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
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.
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.
23 participants (actual enrollment reported by the registry).
First Submitted
March 15, 2021
First Posted
March 17, 2021
Study Start
October 26, 2020
Actual (reported)Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery
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
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
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.
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.
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.
Primary Completion
November 19, 2020
Actual (reported)Study Completion
November 19, 2020
Actual (reported)Last Updated
March 22, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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