search
Back to results

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

Primary Purpose

Cataract, Presbyopia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MINI WELL READY ®
FINE VISION®
Sponsored by
SIFI SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ophtalmologie Hôpital Morvan
  • Clinique Juge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MINI WELL READY ®

FineVision ®

Arm Description

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

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

Outcomes

Primary Outcome Measures

Defocus curve - binocular
Defocus curve assessment

Secondary Outcome Measures

Full Information

First Posted
February 18, 2017
Last Updated
September 1, 2020
Sponsor
SIFI SpA
Collaborators
Opera CRO, a TIGERMED Group Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03060954
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
The clinical study is closed to further enrolment based on the lack of perceived need to compare the study device with the control device.
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SIFI SpA
Collaborators
Opera CRO, a TIGERMED Group Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MINI WELL READY ®
Arm Type
Experimental
Arm Description
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
Arm Title
FineVision ®
Arm Type
Other
Arm Description
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
Intervention Type
Device
Intervention Name(s)
MINI WELL READY ®
Intervention Description
BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
Intervention Type
Device
Intervention Name(s)
FINE VISION®
Intervention Description
FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
Primary Outcome Measure Information:
Title
Defocus curve - binocular
Description
Defocus curve assessment
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Refraction
Description
Ocular refraction evaluation
Time Frame
6 months
Title
Visual Acuity Evaluation
Description
Uncorrected Distance Visual Acuity (UDVA)
Time Frame
6 months
Title
Visual Acuity Evaluation
Description
Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA)
Time Frame
6 months
Title
Visual Acuity Evaluation
Description
Distance Corrected Intermediate Visual Acuity (DCIVA)
Time Frame
6 months
Title
Visual Acuity Evaluation
Description
Uncorrected Near Visual Acuity (UNVA)
Time Frame
6 months
Title
Visual Acuity Evaluation
Description
Distance Corrected Near Visual Acuity (DCNVA)
Time Frame
6 months
Title
Reading speed
Description
Reading speed performance
Time Frame
6 months
Title
Halometry
Description
Halos evaluation
Time Frame
6 months
Title
Contrast sensitivity
Description
Contrast sensitivity evaluation
Time Frame
6 months
Title
Subject satisfaction questionnaire - VF-11R
Description
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
Title
Operative Complications / Postoperative Complications / Adverse Event Assessment
Description
Assessment of Operative Complications, Postoperative Complications, Adverse Events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianluca Stivale
Organizational Affiliation
SIFI SpA
Official's Role
Study Director
Facility Information:
Facility Name
Ophtalmologie Hôpital Morvan
City
Brest
Country
France
Facility Name
Clinique Juge
City
Marseille
ZIP/Postal Code
13008
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs