Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant

Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: MINI WELL Ready (SIFI SpA, Italy)

Detailed Description

The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70121
    • U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects affected by cataract that fulfill eligibility criteria

Description

Inclusion Criteria:

• Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:

• Any gender and age above 18 years.
• Cataract or Refractive Lens Exchange (RLE) surgery; will be included patients submitted to conventional phacoemulsification as to femtolaser procedure; no specification regarding corneal incision size and position.
• Symmetrical preoperative keratometric astigmatism < 1.00 D.
• Healthy corneas, not surgically treated

Exclusion Criteria:

• Previous corneal surgery (i.e. pterygium, refractive surgery).
• Eye diseases with visual acuity < 20/32.
• Pseudoexfoliation.
• Abnormal pupil size and position.
• Use of contact lens 30 days before the preoperative visit.
• Corneal warpage.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MINI WELL Ready (SIFI SpA, Italy); Extended depth of focus intraocular lens implantation	Device: MINI WELL Ready (SIFI SpA, Italy); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Complications Rate of postoperative complication		26 months
Subjective Posterior Capsule Opacification	Subjective assessment through slit lamp	20-26 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

Collaborators and Investigators

• Sponsor: SIFI SpA
• Collaborators: Opera CRO, a TIGERMED Group Company

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): November 19, 2020
• Study Completion (Actual): November 19, 2020

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cataract surgery; Extended Depth-of-Focus (EDOF); Intraocular Lens (IOL); Presbyiopa correction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PSM8 Sub-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No