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Measuring Reading Rehabilitation Outcomes

3 februari 2009 uppdaterad av: US Department of Veterans Affairs
The purpose of this study is to measure the effectiveness of a newly-designed oculomotor training program for patients with age-related macular degeneration.

Studieöversikt

Detaljerad beskrivning

Age-related macular degeneration (AMD) is currently among the top three leading causes of central vision loss in veterans (Chomsky et al., 1995) and is the most prevalent cause of blindness among veterans (37.2%, Quillen & Henry, 2000). The loss of central vision associated with these diseases has a profound impact on the quality of life of those affected, with many suffering depression. It is devastating to no longer be able to read a newspaper or recognize facial expressions. The use of preferred retinal locations (PRLs) to compensate for diseased foveae has offered hope to these patients in regaining some function. The investigators have developed a protocol that includes training in three major visual skills areas:

  • visual awareness and eccentric viewing;
  • reading eye movements; and
  • processing of sequentially presented lexical information.

Module 1 focuses on making the patient aware of better vision at an eccentric location relative to degraded vision at the diseased fovea. Module 2 is focused on the improvement of the control of eye movements with the PRL. Module 3 is focused on reading practice without eye movements. These program curriculums and preliminary results are provided in the present proposal. The primary aim of this proposal is to quantitatively assess the relative effectiveness for improving reading and to establish the minimum training time need for skill improvement. Sixty patients with AMD who are already using a PRL will be selected to be similar in visual characteristics (e.g., visual acuity, contrast sensitivity, size of scotoma, duration of disease) and included in an experimental group. All patients in the experimental group will be trained with all three modules using a repeated measures - completely counterbalanced - design to control for training order effects. An additional 24 AMD patients will be recruited for a control group to be tested at the same time intervals as the experimental patients, but do not receive training between these assessment period intervals. The control group patients will be given the option to receive training following the assessment period. Both the experimental and the control patients will be assessed using the same outcome measures of reading (using MNRead Acuity Charts, the Pepper Visual Skills for Reading (VSR) Test, and the View Sentences Test). The performance of the experimental patients on the outcomes battery post-training will be compared to their pre-training performance on the same battery. Any change in performance of the experimental patients will be compared to the test-retest performance of the control patients. A questionnaire (the Veterans Administration Low Vision Visual Functioning Questionnaire) will also be administered to assess perceived abilities to perform everyday tasks before and following training. The control patients will also receive the questionnaire before and after their assessment period. In addition, the experimental patients will also be assessed on the exercises practiced during the module at the end of each daily training session to determine exactly when in the training protocol an improvement in performance on the exercises being trained has occurred. These daily performance measures provide for a finer scale for detecting performance changes. Statistical analyses will be conducted to answer the following key questions:

  • What visual skills related to reading are trainable?
  • Which methods are best for training these skills?
  • What is the time course of visual skill improvement?
  • Do the answers to these questions depend upon individual patient characteristics (e.g., age, disease severity, PRL location, cognitive factors)?
  • Do patients who do not undergo training, but have repeated reading performance assessments, show improvements in reading skills?

Advances are being made in the area of retinal cell transplantation, gene therapy, and retinal prosthetics. When these techniques become part of standard clinical care, it is likely that the patients will require vision rehabilitation techniques to help them make sense of their potentially fragmented percepts. This research offers an evaluation of relative successes of the components of reading rehabilitation and will lead to the design of an efficient and effective composite training strategy.

Studietyp

Interventionell

Inskrivning (Förväntat)

90

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

    • Illinois
      • Chicago, Illinois, Förenta staterna, 60612
        • Jesse Brown VA Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients with a diagnosis of AMD
  • An established preferred retinal locus
  • Visual acuity of less than or equal to 20/70 and greater than or equal to 20/400 (in the better eye)

Exclusion Criteria:

  • Those with other major ophthalmologic and neurologic disease; choroidal neovascularization ("wet" AMD); moderate to severe media opacities; and cognitive impairment

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vad mäter studien?

Primära resultatmått

Resultatmått
Participants will be given the following assessment tests at 4 different times during the assessment (at baseline, after 6 weeks, after 12 weeks, and after 18 weeks): eye tracking measures, daily performance measures and reading measures.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Janet P Szlyk, Ph.D., Research & Development Service 151, Jesse Brown VA Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2005

Avslutad studie (Faktisk)

1 maj 2008

Studieregistreringsdatum

Först inskickad

28 juli 2005

Först inskickad som uppfyllde QC-kriterierna

28 juli 2005

Första postat (Uppskatta)

1 augusti 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

5 februari 2009

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 februari 2009

Senast verifierad

1 december 2006

Mer information

Termer relaterade till denna studie

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Kliniska prövningar på Retinal degeneration

Kliniska prövningar på Eccentric Viewing Training for Reading

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