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

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03060954
• Other study ID #: PSM29
• Status: Terminated
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: September 2020
• Source: SIFI SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• MINI WELL READY ®
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
• FINE VISION®
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY

Locations

Country	Name	City	State
France	Ophtalmologie Hôpital Morvan	Brest
France	Clinique Juge	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
SIFI SpA	Opera CRO, a TIGERMED Group Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Refraction	Ocular refraction evaluation	6 months
Other	Visual Acuity Evaluation	Uncorrected Distance Visual Acuity (UDVA)	6 months
Other	Visual Acuity Evaluation	Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA)	6 months
Other	Visual Acuity Evaluation	Distance Corrected Intermediate Visual Acuity (DCIVA)	6 months
Other	Visual Acuity Evaluation	Uncorrected Near Visual Acuity (UNVA)	6 months
Other	Visual Acuity Evaluation	Distance Corrected Near Visual Acuity (DCNVA)	6 months
Other	Reading speed	Reading speed performance	6 months
Other	Halometry	Halos evaluation	6 months
Other	Contrast sensitivity	Contrast sensitivity evaluation	6 months
Other	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
Other	Operative Complications / Postoperative Complications / Adverse Event Assessment	Assessment of Operative Complications, Postoperative Complications, Adverse Events	6 months
Primary	Defocus curve - binocular	Defocus curve assessment	6 months