Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003634

Trial Description

start of 1:1-Block title

Title

Market Assessment Tecnis ZMTM

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ZMTM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://NA

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This assessment comprises the evaluation of vision with a new intraocular lens in patients with cataract.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In this feasability study, the visual acuity with a new intraocular lens will be evaluated in patients with bilateral cataract and with a corneal astigmatism to be corrected in at least one eye. The visual acuity for far and near shall be examined in this multicenter, prospective study including the reduction in corneal astigmatism. Patient satisfaction will be evaluated with a questionnaire.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003634
  •   2012/04/27
  •   [---]*
  •   no
  •   Approved
  •   20/12, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   H25-H28 -  Disorders of lens
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Implantation of one new intraocular lens into minimum of one eye. The other eye may receive a standard IOL if there is no existing corneal astigmatism.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The placement of the intraocular lens will be determined 1 day postoperatively and compared with the 3-months postoperative data. The visual acuity for far and near will be evaluated quantitively the 1-week postoperative examination onwards.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Side effects/complications will be evaluated at each postoeprative examination. Patient satisfaction will be evaluated preoperatively and at the final postoperative examination.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
  •   Spain
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/03/23
  •   50
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Healthy patients with bilateral cataracts; women shall not be pregnant or breast-feeding

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Uncontrolled systemic or ocular deseases; participating in another study

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • AMO Germany GmbH
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76275  Ettlingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • AMO Germany GmbH
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76275  Ettlingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • AMO Germany GmbH
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76275  Ettlingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • AMO Germany Vertreter für Europa
    • Mr.  Dr.  Roland  Pohl 
    • Rudolf-Plank-Str. 31
    • 76275  Ettlingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/02/26
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.