Trial document




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  DRKS00004740

Trial Description

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Title

Market Assessment Clinical Study of expanded Design of the Tecnis® Multifocal 1-Piece IOL

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Trial Acronym

DIOL-107-ZMLA

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URL of the Trial

http://-

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Brief Summary in Lay Language

The aim of the study is to restore vision after cataract surgery. The artificial lenses to be tested are designed to enable distance vision, near and the area between them, which are analyzed using standard test methods.

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Brief Summary in Scientific Language

The purpose of this study is to conduct a market assessment with two low-add multifocal intraocular lenses.

The multifocal IOLs provide acceptable clinical results with good distance vision, good vision for near and with distance correction with acceptable complications and side effects.

Primary criteria include the average monocular uncorrected distance vision and monocular distance corrected near vision at the 1-month control.

Secondary criteria are the binocular corrected distance and distance corrected near visual acuity, depth of field and a patient questionnaire. Complications and side effects are to be determined.

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Organizational Data

  •   DRKS00004740
  •   2013/03/01
  •   [---]*
  •   no
  •   Approved
  •   2012-660-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1140-0306 
  •   95.05-5660-8044  (BfArM-Nummer Medizinprodukt)
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Health Condition or Problem studied

  •   H25 -  Senile cataract
  •   H26 -  Other cataract
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Interventions/Observational Groups

  •   The artificial lenses (Tecnis® Multifocal 1-Piece IOL) will be implanted into both eyes of the patients after having removed the cataract.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. monocular uncorrected distance visual acuity with ETDRS reading charts, 1 and 3 months after binocular implantation
2. monocular distance-corrected near vision with ETDRS reading charts, 1 and 3 months after binocular implantation

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Secondary Outcome

1. binocular corrected distance and distance corrected near visual acuity with ETDRS reading charts, 1 and 3 months after binocular implantation
2. depth of field with ETDRS reading charts and set trail fram glasses at 1 and 3 months after binocular implantation
3. questionnaire on patient satisfaction 3 months after binocular implantation
4. complications and side effects at each postoperative examination

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Countries of Recruitment

  •   Germany
  •   Portugal
  •   Belgium
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/03/01
  •   30
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Minimum 18 years of age
• Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned
• Potential for postoperative best-corrected visual acuity of 20/25 or better
• Preoperative corneal astigmatism of 1.0 D or less with no irregular astigmatism
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent to comply with applicable privacy laws pertaining to medical treatment in the governing countries

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Exclusion Criteria

• Requiring an intraocular lens power outside the available range of +16.0 to +28.0 D
• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes
• Prior refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 20/30 or worse during the study
• Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
• Use of systemic or ocular medications that may affect vision
• Prior, current, or anticipated use during the course of the 12-month study of tamsulosin or silodosin (e.g., Flomax®, Flomaxtra®, Rapaflo®) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery
• Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: ocular hypertension without glaucomatous changes is acceptable.
• Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
• Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial

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Addresses

  • start of 1:1-Block address primary-sponsor
    • AMO Debbie Trentacost
    • Ms. 
    • 1700 East St. Andrew Place
    • 92705-4933  Santa Ana
    • United States
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    • AMO Vertreter für Europa
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76274  Ettlingen
    • Germany
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    • AMO Vertreter für Europa
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76274  Ettlingen
    • Germany
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Sources of Monetary or Material Support

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    • AMO Vertreter für Europa
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76274  Ettlingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/08/20
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.