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

Study Overview
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Brief Summary
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Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial

Detailed Description
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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.

Official Title
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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.

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: MINI WELL READY ®
* Device: FINE VISION®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MINI WELL READY ®<br>BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY | Device: MINI WELL READY ®<br>* BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY<br>|
| Other: FineVision ®<br>FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY | Device: FINE VISION®<br>* FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY<br>|

What is the study measuring?
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Primary Outcome Measures

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