Trial document





This trial has been registered retrospectively.
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  DRKS00007837

Trial Description

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Title

Composition of a database for quality management and optimization of the postoperative results of premium intraocular lenses

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The aim of this study is the ahort and Long term Evaluation of modern CE certified premium intraocular lenses with the composition of a database for Quality Management as well as optimization of the IOL calculation constants for IOL power calculations. Routinly operated patients shall be included over several years postoperatively. On the one hand a retrospective Analysis of the preoperative data shall take place, on the other hand the patients shall be evaluated prospectively after 3 month and possibly after 1 and 3 years. Planed parameters are: Refraction, visual acuity measurements, slitlamp examination, Fundus in Mydriasis, keratometry, photo documentation and a subjective Patient questionaire. Depending on the type of implanted IOL one or more diagnostic examinations will take place (wavefront measurement, corneal topography, measurement of accomodation, contrast Vision, stray light measurements). All examinations are well-established, certified and non-invasive.

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Organizational Data

  •   DRKS00007837
  •   2015/03/09
  •   [---]*
  •   yes
  •   Approved
  •   S-392/2011, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   H25.1 -  Senile nuclear cataract
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Interventions/Observational Groups

  •   Patients implanted with premium intraocular lenses are prospectively examined after 3 month, 1 year and 3 years for visual acuity, refraction and evaluation of visual quality. The preoperative data is retrospectively evalluated
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Characteristics

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

Deviation target vs. achieved postoperative refraction (for IOL constant optimization) after 3 month only

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Secondary Outcome

Functional results (refraction, visual acuity), subjective Patient satisfaction, Quality of Vision (contrast, spherical Aberration), stability of postoperative achieved results
Preoperative data is evaluated retrospectively from pseudonymisiced patient files. The patients will be rescheduled for all examinations after 3 month, 1 year and 3 years.
Patient satisfaction will be evaluated by self developed subjective questionaire

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2011/11/22
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Condition after monocular or binocular Implantation of a premium intraocular lens and expectaed good visual Rehabilitation (visual acuity ≥0.3 logMAR)
female and male > 18 Jahren
signed informed consent
legal capacity

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Exclusion Criteria

preexsiting visual acuity limitating ocular surgeries or ocular pathologies, intraoperative complications (capsular rupture, anterior vitrektomie), demtia, pregnancy and lactation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • International Vision Correction Research Centre (IVCRC), UNiversitäts-Augenklinik Heidelberg
    • Mr.  Prof. Dr. med.  Gerd  Auffarth 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • International Vision Correction Research Centre (IVCRC) & David J Apple International Laboratory for Ocular Pathology, University Eye Clinic, Heidelberg
    • Mr.  Dr. med.  Florian  Kretz 
    • Im Neuenheim Feld 400
    • 69120  Heidelberg
    • Germany
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    • International Vision Correction and Research Centre (IVCRC), Universitäts-Augenklinik Heidelberg
    • Ms.  Raquel  Willrich 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-Augenklink Heidelberg
    • Mr.  Prof. Dr. med.  Gerd  Auffarth 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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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.