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Completed

NCT Number: NCT02838004

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof.Dr. Gerd U. Auffarth

Heidelberg, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IOL MINI WELL READY

Device

IOL MINI WELL READY

Primary outcomes

  1. UDVA (Uncorrected Distance Visual Acuity)

    Time frame: 30 days

    Visual acuity mesurement

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

SIFI SpA

Industry

Collaborators

  • Opera CRO, a TIGERMED Group Company

Registry information

Official study 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

Acronym: PSM15

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2016
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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