Trial document




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  DRKS00010887

Trial Description

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Title

Evaluation of the adjustment of low vision aids in patients with visual impairment due to corneal diseases

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Trial Acronym

Cornea LVA

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of the current situtation of patients with visual impairment due to corneal diseases, especially relating to Low Vision Aids (LVAs). Thus, the treatment of these patients should be improved.
Subjects have to perform standardized reading tests with different LVAs, to evaluate the best suitable. Furthermore the costs, problems and the user behaviour of these patients with LVAs are assessed via a standardized questionnaire.

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Brief Summary in Scientific Language

Evaluation of the current situation of patients with visual impairment due to corneal diseases (e.g. corneal opacities due to chemical burns, corneal dystrophies, Keratoconus).
This study should improve the visual rehabilitation of these patients.
Subjects undergo detailed examinations to assess the current status of their disease. In Addition they have to perform standardized reading speed tests with different LVAs, to evaluate the best suitable LVA for these patients. Furthermore the costs, problems and user behavior of these patients with LVAs are assessed with a standardized questionnaire (Low Vision Aid Questionnaire, LVAQ-15).To assess the visual function subjects undergo, besides Near and Distance visual acuity testing (ETDRS), a specific test of the ability to perform tasks of daily living. This "Compressed Assessment of Activities Related to Vision" (CAARV) consists of 4 different tests.

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Organizational Data

  •   DRKS00010887
  •   2016/08/09
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  •   yes
  •   Approved
  •   16-6879-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1185-7119 
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Health Condition or Problem studied

  •   H17.1 -  Other central corneal opacity
  •   H18.6 -  Keratoconus
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Interventions/Observational Groups

  •   Assessment of reading speed with different Low Vision Aids using the International reading speed text (IReST) test.
    Low vision aid: Optical magnifying glass
  •   Low vision aid: Electronic magnifying device
  •   Low vision aid: Desktop Video magnifier
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   IV
  •   N/A
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Primary Outcome

Assessment of the LVA (Low Vision Aid) with the highest reading Speed using "International reading Speed text" (IReST) in patients with visual impairment due to corneal diseases

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Secondary Outcome

• Evaluate costs, problems and user behaviour of patients with corneal diseases
related to LVAs (LVAQ-15)
• Evaluate ability to perform tasks daily living in patients with corneal diseases (CAARV)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/09/10
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Corneal dystrophies or corneal scars after chemical/ thermal burns or corneal damage induced by ocular GvHD or limbal stem cell deficiency
2. Or Keratoconus which cannot be treated by contact lens
3. Best corrected visual acuity (BCVA) ≤ 0,3 in the better eye
4. Fluent german
5. No Intention of corneal transplantation (PKP, DMEK, DSAEK etc.), amnion membrane transplantation and/or limbal stem cell transplantation
6. Written informed consent

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Exclusion Criteria

1. Nystagmus
2. Analphabetism
3. Diagnosed depression
4. Intended corneal transplantation
5. Function loss because of other diseases of retina, the optical nerve and vitreous body
6. Uncontrolled pathological intraocular pressure

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Zentrum für Augenheilkunde des Universitätsklinikums Essen
    • Mr.  Michael  Oeverhaus 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Zentrum für Augenheilkunde des Universitätsklinikums Essen
    • Ms.  Ulrike  Kaiser 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • QD Laser Deutschland GmbH
    • Lindenallee 55
    • 45127  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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