Clinical trial NCT03060954: Non-Inferiority Study Comparing MINI WELL READY® and FineVision® in Patients With Cataract Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Presbyopia
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2017-02-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Defocus curve - binocular
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Refraction
timeFrame: 6 months
measure: Visual Acuity Evaluation
timeFrame: 6 months
measure: Visual Acuity Evaluation
timeFrame: 6 months
measure: Visual Acuity Evaluation
timeFrame: 6 months
measure: Visual Acuity Evaluation
timeFrame: 6 months
measure: Visual Acuity Evaluation
timeFrame: 6 months
measure: Reading speed
timeFrame: 6 months
measure: Halometry
timeFrame: 6 months
measure: Contrast sensitivity
timeFrame: 6 months
measure: Subject satisfaction questionnaire - VF-11R
timeFrame: 6 months
measure: Operative Complications / Postoperative Complications / Adverse Event Assessment
timeFrame: 6 months
Locations:
city: Brest
country: France
facility: Ophtalmologie Hôpital Morvan
city: Marseille
country: France
facility: Clinique Juge
Study officials:
affiliation: SIFI SpA
name: Gianluca Stivale
role: STUDY_DIRECTOR
References: