Trial document




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  DRKS00003181

Trial Description

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Title

PILOT CLINICAL INVESTIGATION OF THE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS, MODEL 1R211R

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Trial Acronym

101.211R

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URL of the Trial

http://

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Brief Summary in Lay Language

Background:
In this study, patients with cataracts shall be enrolled. After removal of the cataract, an intraocular lens (=IOL) shall be implanted to enable vision in different distances.
The purpose of the study is to evaluate the vision with the study lens in different distances in comparison zu theTECNIS® One-Piece lens, which provides only in one distance good vision.
The hypothesis is:
The study lens provides an increased vision from far to near as compared to the control lens.

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Brief Summary in Scientific Language

multicenter, multi-national, prospective, comparative, double-masked, intra-individuel

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Organizational Data

  •   DRKS00003181
  •   2011/08/02
  •   [---]*
  •   no
  •   Approved
  •   73/11, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

  •   95.06-5660-6710  (BfArM-Nummer Medizinprodukt)
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Health Condition or Problem studied

  •   GRAUERSTAR
  •   H25 -  Senile cataract
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Interventions/Observational Groups

  •   The patient will receive the study lens (model 1R211R) into one eye and the control lens (TECNIS® One-Piece monofocal IOL) into the other eye. This process is randomized.
  •   Patient will receive the study lens into both eyes (model 1R211R).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Active control
  •   Treatment
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

The visual acuity of patients will be determined in different distances one and three months after implantation of the IOLs. A questionnaire on the satisfaction of the patients will be filled in.

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Secondary Outcome

Advers events according ISO 14155 will be evaluated during the course of the study. During the postoperative examinations after 1 and 3 months, optical-visual symptoms, lens related and medical complications will be evaluated. A questionnaire for the subjective satisfaction of the patients will be performed.

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Actual
  •   2011/07/04
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Healthy patients with bilateral cataract; women must not be pregnant or breast-feeding

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Exclusion Criteria

uncontrolled systemic or oculare deseases; participation in another study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • AMO Germany Vertretung für Europa
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76275  Ettlingen
    • Germany
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    • AMO Germany Vertreter für Europa
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76275  Ettlingen
    • Germany
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  • start of 1:1-Block address public-contact
    • 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 Germany Vertreter für Europa
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76275  Ettlingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/01/10
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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.