Non-Inferiority Study Comparing MINI WELL READY® and FineVision® in Patients With Cataract Surgery

A Multicentre, Controlled, Randomised, Single-blind, Two-armed Trial Evaluating the Visual Performance, Quality of Vision and Subjective Outcomes After Bilateral Implantation of MINI WELL Ready® or FineVision® in Patients With Cataract Surgery.

Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial

Study Overview

• Status: Terminated
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Device: MINI WELL READY ®; Device: FINE VISION®

Detailed Description

To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France
    • Ophtalmologie Hôpital Morvan
  • Marseille, France, 13008
    • Clinique Juge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Bilateral cataract surgery required, no other ocular comorbidities
• Healthy corneas, not treated surgically
• Available for second-eye surgery within 1 week of the initial operation
• Spherical refraction between -8.00D and +6.00D
• Willing to adhere to the study visit schedule
• Normal anterior and posterior segments
• Clear intraocular media - other than cataract
• To benefit from a social security system before being enrolled
• Written informed consent consistent with local regulation research in human subjects

Exclusion Criteria:

• Any previous history of ocular trauma or prior ocular surgery (including previous cataract surgery and CLRIs)
• Ocular comorbidities determining potential postoperative Visual Acuity less than 0.50 decimal (0.3 logMAR)
• Expected to require retinal laser treatment
• A history of retinal detachment or predisposition for such disorder
• Psudoexfoliation
• Abnormal pupil size and position
• Pupil size > 7 mm under mesopic condition
• Use of contact lenses 30 days before the preoperative visit
• Corneal warpage (e.g. Keratoconus, Pellucid Marginal Corneal Degeneration or Keratoglobus)
• Corneal astigmatism greater than 0.75D
• Zonular laxicity
• Absence of adequate capsular support for the implant of the intraocular lens in the capsular bag
• Microphthalmus
• Active ocular disease in the operative eye, for example, chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency (such as Fuch's endothelial dystrophy)
• Suspected microbial infection
• Irregularities and capsulorexis decentralization
• Surgical difficulties that may increase the risk of complications such as persistent bleeding, significant iris damage, an uncontrollable intraocular hypertonia, or damage due to significant vitreous loss
• Patients in whom the intraocular lens may interfere with the ability to observe, diagnose or treat diseases of the posterior segment
• Patients in whom neither the posterior capsule nor the zonula can provide adequate support to the lens
• Subjects with any systemic disease that could increase operative risk or confound the outcome
• Pregnant or lactating or planning a pregnancy at the time of enrolment
• Vulnerable subjects (children <18 years, people in guardianship or trusteeship or inability to give an informed consent)
• Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MINI WELL READY ®; BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY	Device: MINI WELL READY ®; BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
OTHER: FineVision ®; FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY	Device: FINE VISION®; FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defocus curve - binocular	Defocus curve assessment	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refraction	Ocular refraction evaluation	6 months
Visual Acuity Evaluation	Uncorrected Distance Visual Acuity (UDVA)	6 months
Visual Acuity Evaluation	Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA)	6 months
Visual Acuity Evaluation	Distance Corrected Intermediate Visual Acuity (DCIVA)	6 months
Visual Acuity Evaluation	Uncorrected Near Visual Acuity (UNVA)	6 months
Visual Acuity Evaluation	Distance Corrected Near Visual Acuity (DCNVA)	6 months
Reading speed	Reading speed performance	6 months
Halometry	Halos evaluation	6 months
Contrast sensitivity	Contrast sensitivity evaluation	6 months
Subject satisfaction questionnaire - VF-11R	Subject satisfaction questionnaire - VF-11R "revised version": Annex A: Subject's glasses independence and light dependence Annex B: Quality of Vision (QoV) questionnaire	6 months
Operative Complications / Postoperative Complications / Adverse Event Assessment	Assessment of Operative Complications, Postoperative Complications, Adverse Events	6 months

Collaborators and Investigators

• Sponsor: SIFI SpA
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Study Director: Gianluca Stivale, SIFI SpA

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2019
• Primary Completion (ACTUAL): March 5, 2020
• Study Completion (ACTUAL): March 5, 2020

Study Registration Dates

• First Submitted: February 18, 2017
• First Submitted That Met QC Criteria: February 18, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: PSM29

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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