A Multi-Center Study of Reading Rehabilitation in Macular Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00746668
First received: September 3, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to measure the effectiveness of a newly-designed oculomotor training program for patients with macular disease, including age-related macular degeneration.


Condition Intervention
Age Related Maculopathy
Retinal Degeneration
Behavioral: Eccentric Viewing Training for Reading

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: A Multi-Center Study of Reading Rehabilitation in Macular Disease

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Participants will be given the following assessment tests at 3 different times during the assessment (at baseline, after 4 weeks, post-training): daily performance measures, reading measures, and questionnaires. [ Time Frame: Pre-training, 4 weeks after training, post-training ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: August 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Eccentric Viewing Training for Reading
Behavioral: Eccentric Viewing Training for Reading
Eccentric viewing training for reading.

Detailed Description:

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 to 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 two major visual skills areas:

  • Visual awareness and eccentric viewing; and
  • Reading practice with sequentially 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 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. One hundred and twenty patients with macular disease who are already using a PRL and similar in visual characteristics (e.g., visual acuity, contrast sensitivity, size of scotoma, duration of the disease) will be included the study. All patients will be trained with both modules using a repeated measures-completely counterbalanced - design to control for training order effects. In addition, all patients will be assessed using the same outcome measures of reading (using MNRead Acuity Charts and the View Sentences Test). The performance of the patients on the outcomes battery post-training will be compared to their pre-training performance on the same battery. Questionnaires (the Veterans Administration Low Vision Visual Functioning Questionnaire, CES-D, Short Form-36, and Adaptation to Vision Loss Scale) will also be administered to assess perceived abilities to perform everyday tasks, adaptation to vision loss, moods, and general health. In addition, 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 questions:

  • Does a combination of eccentric viewing awareness and oculomotor training produce significant improvements in reading rate?
  • Which exercises are most effective in training the visual skills associated with reading and at what point during the course of training do the patients reach asymptotic performance?
  • How do co-factors such as age, PRL size and location, and cognitive capabilities relate to training outcomes?

Advancements are being made in the area of retinal cell transplantation, gene therapy, and retinal prosthetics. When these techniques become part of the standard clinical care, it is likely that all 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of macular disease, such as age-related macular degeneration
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746668

Locations
United States, Illinois
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Principal Investigator: Janet Szlyk, PhD Jesse Brown VAMC (WestSide Division)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00746668     History of Changes
Other Study ID Numbers: C6246-R
Study First Received: September 3, 2008
Last Updated: November 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Reading
Macular Degeneration
Rehabilitation
Vision, Low

Additional relevant MeSH terms:
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014