Trial document





This trial has been registered retrospectively.
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  DRKS00000784

Trial Description

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Title

Analysis of the "Salzburg Reading Desk"

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to evaluate the repeatability and observer independence of the Salzburg Reading Desk (SRD). Background: Presbyopia, the age-related loss of near vision usually occurs beginning at around age 40.
Traditionally, people with presbyopia have used corrective eyewear to see things clearly at a close distance.
Increasingly, new methods of refractive surgery are being developed with the aim of restoring sight in the vicinity again.
However, there is no satisfactory and sufficiently standardized valuation method for testing near vision before and after surgery and compare operating procedures.
Differences in reading samples and environmental conditions allow only a limited comparability.
With the development of the SRD, a new instrument was developed with the aim to allow a repeatable and standardized measurement of reading skills.
60 persons will be measured for two time-displaced test runs (repeat assessment 3-4 weeks after the initial examination).

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Brief Summary in Scientific Language

The "Salzburg Reading Desk" (SRD) was developed with the aim to allow a repeatable and standardized measurement of reading skills. In this prospective pilot study, the validity of the SRD is examined. 60 people in two age groups (group 1: 21 to 31 years.
Group 2: 38 to 49 years) are tested twice with an interval of 4 weeks.
At the beginning of the measurements corneal topography and wavefront aberrations are recorded monocularly.
On a high resolution TFT screen Radner charts and Snellen charts are shown with different
contrast and lighting conditions.
reading vision, near vision and critical print size are assessed.
The repeatability of the measurements is tested using Bland-Altman analysis.

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Organizational Data

  •   DRKS00000784
  •   2011/05/30
  •   [---]*
  •   yes
  •   Approved
  •   288/09, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   healthy test person
  •   H52.4 -  Presbyopia
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Interventions/Observational Groups

  •   Measuring reading skills of peple aged 21 to 31 with the Salzburg Reading Desk. Two time-displaced test runs (repeat measurement 3-4 weeks after the initial examination)
  •   Measuring reading skills of peple aged 38 to 49 with the Salzburg Reading Desk. Two time-displaced test runs (repeat measurement 3-4 weeks after the initial examination)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
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Primary Outcome

Two-time determination of reading vision and near vision in a time interval of 3-4 weeks with the Salzburg Reading Desk.

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Secondary Outcome

Two-time determination of Reading speed (words/minute) and "Critical Print Size" (the smallest print size with a highest reading speed similar to larger print sizes) in a time interval of 3-4 weeks with the Salzburg Reading Desk.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/12/17
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   49   Years
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Additional Inclusion Criteria

- Myopia/Hyperopia up to 5D, while a spherical äquivalent of -0,5D to +0,5D and astigmatism up to +/-0,5 is defined as emmetropia.
- corrected distance visual acuity of at least 0,8 monocular and 1,0 binocular.
- binocular vision
- round, centrated and aktive pupil.
- minimal reading speed of 80 wpm.
- sufficient cognitive and linguistic abilities

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Exclusion Criteria

-Severe acute or chronic eye diseases such as corneal opacities, glaucoma, advanced cataract, diabetes, retinopathy, macular or peripheral retinal disease.
-Already-performed eye surgery
-participation in other studies, up to four weeks prior to enrollment

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Wolfgang Goethe-Universität
    • Mr.  Priv-Doz. Dr. med. Dr. med. habil  Martin  Baumeister 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinikum der Wolfgang Goethe-Universität
    • Mr.  Priv-Doz. Dr. med. Dr. med. habil  Martin  Baumeister 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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    • Klinikum der Johann Wolfgang Goethe Universität
    • Ms.  Christine   Titke 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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