CClinicalTrials.gg
TerminatedNCT03060954Updated Sep 3, 2020

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

An interventional study of MINI WELL READY ® and FINE VISION® in Cataract and Presbyopia, sponsored by SIFI SpA. Terminated at 2 sites in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by SIFI SpA · Not applicable, Interventional, and Other

Why this study was terminated
The clinical study is closed to further enrolment based on the lack of perceived need to compare the study device with the control device.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cataract
  • Presbyopia
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 8 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    MINI WELL READY ®

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

    Device: MINI WELL READY ®

  • Other
    FineVision ®

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

    Device: FINE VISION®

Interventions

  • DeviceMINI WELL READY ®

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

  • DeviceFINE VISION®

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

06

What researchers measure

Primary outcomes

  1. Defocus curve - binocular

    Defocus curve assessment

    Time frame: 6 months

Other outcomes

  1. Refraction

    Ocular refraction evaluation

    Time frame: 6 months

  2. Visual Acuity Evaluation

    Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 6 months

  3. Visual Acuity Evaluation

    Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 6 months

  4. Visual Acuity Evaluation

    Distance Corrected Intermediate Visual Acuity (DCIVA)

    Time frame: 6 months

  5. Visual Acuity Evaluation

    Uncorrected Near Visual Acuity (UNVA)

    Time frame: 6 months

  6. Visual Acuity Evaluation

    Distance Corrected Near Visual Acuity (DCNVA)

    Time frame: 6 months

  7. Reading speed

    Reading speed performance

    Time frame: 6 months

  8. Halometry

    Halos evaluation

    Time frame: 6 months

  9. Contrast sensitivity

    Contrast sensitivity evaluation

    Time frame: 6 months

  10. 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

    Time frame: 6 months

  11. Operative Complications / Postoperative Complications / Adverse Event Assessment

    Assessment of Operative Complications, Postoperative Complications, Adverse Events

    Time frame: 6 months

07

Study locations

2 sites
  • Ophtalmologie Hôpital Morvan
    Brest, France
  • Clinique Juge
    Marseille, 13008, France
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03060954
Lead sponsor
SIFI SpA
Collaborators
Opera CRO, a TIGERMED Group Company
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
Feb 10, 2019
Primary completion
Mar 5, 2020
Completion
Mar 5, 2020
Last update
Sep 3, 2020

Study contacts

Gianluca Stivale
study director · SIFI SpA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion