NCT03060954

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
2 years until next milestone

Study Start

First participant enrolled

February 10, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

February 18, 2017

Last Update Submit

September 1, 2020

Conditions

CataractPresbyopia

Outcome Measures

Primary Outcomes (1)

  • Defocus curve - binocular

    Defocus curve assessment

    6 months

Other Outcomes (11)

  • Refraction

    6 months

  • Visual Acuity Evaluation

    6 months

  • Visual Acuity Evaluation

    6 months

  • +8 more other outcomes

Study Arms (2)

MINI WELL READY ®

EXPERIMENTAL

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

Device: MINI WELL READY ®

FineVision ®

OTHER

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

Device: FINE VISION®

Interventions

MINI WELL READY ®DEVICE

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

MINI WELL READY ®
FINE VISION®DEVICE

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

FineVision ®

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ophtalmologie Hôpital Morvan

Brest, France

Location

Clinique Juge

Marseille, 13008, France

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Gianluca Stivale

    SIFI SpA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2017

First Posted

February 23, 2017

Study Start

February 10, 2019

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations

FR(2)