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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03060954
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Opera CRO, a TIGERMED Group Company
Information provided by (Responsible Party):
SIFI SpA

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

Condition or disease Intervention/treatment Phase
Cataract Presbyopia Device: MINI WELL READY ® Device: FINE VISION® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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.
Actual Study Start Date : February 10, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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 ®
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
Device: FINE VISION®
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY




Primary Outcome Measures :
  1. Defocus curve - binocular [ Time Frame: 6 months ]
    Defocus curve assessment


Other Outcome Measures:
  1. Refraction [ Time Frame: 6 months ]
    Ocular refraction evaluation

  2. Visual Acuity Evaluation [ Time Frame: 6 months ]
    Uncorrected Distance Visual Acuity (UDVA)

  3. Visual Acuity Evaluation [ Time Frame: 6 months ]
    Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA)

  4. Visual Acuity Evaluation [ Time Frame: 6 months ]
    Distance Corrected Intermediate Visual Acuity (DCIVA)

  5. Visual Acuity Evaluation [ Time Frame: 6 months ]
    Uncorrected Near Visual Acuity (UNVA)

  6. Visual Acuity Evaluation [ Time Frame: 6 months ]
    Distance Corrected Near Visual Acuity (DCNVA)

  7. Reading speed [ Time Frame: 6 months ]
    Reading speed performance

  8. Halometry [ Time Frame: 6 months ]
    Halos evaluation

  9. Contrast sensitivity [ Time Frame: 6 months ]
    Contrast sensitivity evaluation

  10. Subject satisfaction questionnaire - VF-11R [ Time Frame: 6 months ]

    Subject satisfaction questionnaire - VF-11R "revised version":

    Annex A: Subject's glasses independence and light dependence Annex B: Quality of Vision (QoV) questionnaire


  11. Operative Complications / Postoperative Complications / Adverse Event Assessment [ Time Frame: 6 months ]
    Assessment of Operative Complications, Postoperative Complications, Adverse Events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060954


Contacts
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Contact: Gianluca Stivale, PharmD +390957922335 gianluca.stivale@sifigroup.com
Contact: Loretta Aureli +39 3346975759 loretta.aureli@sifigroup.com

Locations
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France
Ophtalmologie Hôpital Morvan Recruiting
Brest, France
Contact: Prof. Béatrice Cochener, MD         
Sponsors and Collaborators
SIFI SpA
Opera CRO, a TIGERMED Group Company
Investigators
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Principal Investigator: Prof. Béatrice Cochener, MD Ophtalmologie Hôpital Morvan, Brest, France
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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT03060954    
Other Study ID Numbers: PSM29
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors