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Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens (PSM15)

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: NCT02838004
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Opera CRO, a TIGERMED Group Company
Information provided by (Responsible Party):
SIFI SpA

Brief Summary:
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.

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

Detailed Description:
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Actual Study Start Date : August 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Single arm receiving Mini WELL Ready IOL
IOL implantation for cataract
Device: IOL MINI WELL READY
IOL MINI WELL READY




Primary Outcome Measures :
  1. UDVA (Uncorrected Distance Visual Acuity) [ Time Frame: 30 days ]
    Visual acuity mesurement


Secondary Outcome Measures :
  1. Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE). [ Time Frame: 4 months ]
    Safety assessment


Other Outcome Measures:
  1. Visual Acuity Evaluation [ Time Frame: 4 months ]
    Corrected Distance Visual Acuity (CDVA)

  2. Visual Acuity Evaluation [ Time Frame: 4 months ]
    Uncorrected Near Visual Acuity (UNVA)

  3. Visual Acuity Evaluation [ Time Frame: 4 months ]
    Distance-Corrected Near Visual Acuity (DCNVA)

  4. Visual Acuity Evaluation [ Time Frame: 4 months ]
    Corrected Near Visual Acuity (CNVA)

  5. Visual Acuity Evaluation [ Time Frame: 4 months ]
    Uncorrected Intermediate Visual Acuity (UIVA)

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

  7. Halos and Glare evaluation [ Time Frame: 4 months ]
    Onset of halos Onset of glare during night vision

  8. Contrast sensitivity [ Time Frame: 4 months ]
    Contrast sensitivity, at 3 meters, under photopic conditions and with the correction for distance, using YANG SMART (SIFI Medtech), with sine wave gradings (''vistech")

  9. Reading Performance [ Time Frame: 4 months ]

    Reading Performance tested with Radner Reading Chart - Precision Vision:

    The test will be performed from the largest to the smallest size of letters in two sessions:

    • Binocular, without the correction for distance, at 40 cm
    • Binocular, with the correction for distance, at 40 cm

  10. Defocus Curve [ Time Frame: 4 months ]
    Binocular defocus curves with step of 0.5 D (from +2.0 to -5.0 D) under photopic conditions.



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

Inclusion Criteria:

  • Any gender and age above 18 years.
  • Refractive lens exchange (RLE) or cataract surgery.
  • Healthy corneas, not treated surgically.
  • Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
  • Patients request to receive the IOL MINI WELL READY implant

Exclusion Criteria:

  • Previous corneal surgery (i.e. pterygium, refractive surgery).
  • Eye diseases determining a probable postoperative visual acuity < 20/40.
  • Pseudoexfoliation.
  • Abnormal pupil size and position.
  • Use of contact lens 30 days before the preoperative visit.
  • Corneal warpage.
  • Predicted postoperative corneal astigmatism higher than 1 D.

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): NCT02838004


Locations
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Germany
Prof.Dr. Gerd U. Auffarth
Heidelberg, Germany
Sponsors and Collaborators
SIFI SpA
Opera CRO, a TIGERMED Group Company
Investigators
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Principal Investigator: GERD U. AUFFARTH, Prof. Dr. RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG

Publications:

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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT02838004     History of Changes
Other Study ID Numbers: PSM15
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by SIFI SpA:
Refractive lens exchange (RLE) or cataract surgery
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors