ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03060954
Recruitment Status : Unknown
Verified February 2017 by SIFI MedTech Srl.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Opera Contract Research Organization SRL
Information provided by (Responsible Party):
SIFI MedTech Srl

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

Condition or disease Intervention/treatment Phase
Visual Disorder 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre, Controled, Randomised, Singleblind, Two-armed, Non Inferiority Trial Evaluating the Visual Performance,Quality of Vision After Bilateral Implantation of MINI WELL READY®, or FINEVISION® in Patients With Cataract Surgery
Estimated Study Start Date : February 28, 2018
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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: 2- 6 months ]

Secondary Outcome Measures :
  1. Refraction [ Time Frame: 2- 6 months ]
  2. Reading speed at 40cm [ Time Frame: 2- 6 months ]
  3. Contrast sensitivity - binocular distance [ Time Frame: 2- 6 months ]

Other Outcome Measures:
  1. Uncorrected Distance Visual Acuity [ Time Frame: 2- 6 months ]


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.


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

Inclusion Criteria:

  • 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
  • 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 s)
  • Ocular comorbidities determining potential postoperative Visual Acuity less than 0.50 decimal (0.3 logMAR)
  • Expected to require retinal laser treatment
  • 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
  • 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)
  • 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
  • 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
Contact: Gianluca Stivale, PharmD +390957922335 gianluca.stivale@sifigroup.com
Contact: Dionisio Barattini, MD +393355437574 barattini@operacro.com

Locations
Romania
Opera Contract Research Organization Srl
Timisoara, Timis, Romania, 300209
Sponsors and Collaborators
SIFI MedTech Srl
Opera Contract Research Organization SRL
Investigators
Principal Investigator: Béatrice Cochener, Prof. Ophtalmologie Hôpital Morvan, Brest, FRANCE

Responsible Party: SIFI MedTech Srl
ClinicalTrials.gov Identifier: NCT03060954     History of Changes
Other Study ID Numbers: PSM29
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SIFI MedTech Srl:
Visual Disorder

Additional relevant MeSH terms:
Cataract
Vision Disorders
Lens Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms