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

SIFI

Status

Terminated

Conditions

Cataract

Presbyopia

Treatments

Device: MINI WELL READY ®

Device: FINE VISION®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03060954

PSM29

Details and patient eligibility

About

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

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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