Trial document




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  DRKS00007826

Trial Description

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Title

STUDY TO PERFORM A CORNEAL MEASUREMENT METHOD FOR THE CATALYS® SYSTEM

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Trial Acronym

CMAA-102-OS40

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A CE marked measurement attachment (software and lens device) as part of a laser will be used to measure the corneal astigmatism. During the study only measurements of the cornea without contacting the eye of the patient will be conducted, to determine the steep axis of the cornea before a cataract laser treatment which is not part of the study.

Study objective is to evaluate measurements to determine the steep meridian of the cornea before the laser treatment.

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Brief Summary in Scientific Language

The SMRT device is CE marked and measures the steep axis in a non-contact way before the laser treatment. SMRT means Steep Meridian Registration Technology.Subjects who agree to participate will be enrolled in the study upon signing the informed consent. Preoperative baseline evaluation will be compared to the steep meridian measurments.

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Organizational Data

  •   DRKS00007826
  •   2015/02/18
  •   [---]*
  •   no
  •   Approved
  •   5147-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   Z01.0 -  Examination of eyes and vision
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Interventions/Observational Groups

  •   The first eye of enrolled subjects shall be measured once with the SMRT device before the Laser treatment.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

SMRT measurement success rate

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Secondary Outcome

non

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/02
  •   90
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

*Male or female at least 22 years of age at the time of preoperative examination
*At least 0.5 D of corneal cylinder
*Clear intraocular media, except for the presence of cataract
*Willing and able to participate in the study
*Able to fixate
*Signed informed consent

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Exclusion Criteria

*History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
*Evidence of keratoconus or abnormal topography in the study eye(s), which in the opinion of the investigator would confound the study results.
*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
    • OptiMedica Corporation
    • Ms.  Priya  Janakiraman 
    • 1310 Moffett Park Drive
    • 94089  Sunnyvale
    • United States
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    •   +1-714-247-8625
    •   [---]*
    •   [---]*
    •   [---]*
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    • AMO Germany GmbH
    • Mr.  Dr. rer. nat.  Roland  Pohl 
    • Rudolf Plank Str 31
    • 76275  Ettlingen
    • Germany
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    • AMO Germany GmbH
    • Mr.  Dr. rer. nat.  Michael  Faust 
    • Rudolf Plank Str 31
    • 76275  Ettlingen
    • Germany
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Sources of Monetary or Material Support

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    • OptiMedica Corporation
    • Ms.  Priya  Janakiraman 
    • 1310 Moffett Park Drive
    • 94089  Sunnyvale
    • United States
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    •   +1-714-247-8625
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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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.