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

NCT ID: NCT03060954

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2020-03-05

Brief Summary

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

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.

Conditions

Cataract; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

MINI WELL READY ®

BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY

Group Type: EXPERIMENTAL

MINI WELL READY ®

Intervention Type: DEVICE

BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY

FineVision ®

FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY

Group Type: OTHER

FINE VISION®

Intervention Type: DEVICE

FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY

Interventions

MINI WELL READY ®

BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY

Intervention Type: DEVICE

FINE VISION®

FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

SIFI SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianluca Stivale

Role: STUDY_DIRECTOR

SIFI SpA

Locations

Ophtalmologie Hôpital Morvan

Brest, , France

Clinique Juge

Marseille, , France

Countries

France

Other Identifiers

PSM29

Identifier Type: -

Identifier Source: org_study_id