A Multi-Center Study of Reading Rehabilitation in Macular Disease

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Retinal Degeneration; Age Related Maculopathy

Treatments: Behavioral: Module 2: Control of Reading Eye Movements; Behavioral: Module 3: Reading Practice with RSVP; Behavioral: Module 1: Visual Awareness and Eccentric Viewing

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00746668

C6246-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 7 patient groups

Control Group

Experimental group

Description:

Subjects randomly assigned to this group had their training delayed for 18 weeks. These subjects underwent four assessments: baseline and at three 6-week intervals' but, they were not given any training during this time. After this data collection period, these control subjects were given training on the three modules. However, their performance after each period of training was not assessed.

Treatment:

Behavioral: Module 2: Control of Reading Eye Movements

Behavioral: Module 3: Reading Practice with RSVP

Behavioral: Module 1: Visual Awareness and Eccentric Viewing

Group 1

Experimental group

Description:

The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 3 (Reading Practice with RSVP)

Treatment:

Behavioral: Module 2: Control of Reading Eye Movements

Behavioral: Module 3: Reading Practice with RSVP

Behavioral: Module 1: Visual Awareness and Eccentric Viewing

Group 2

Experimental group

Description:

The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)

Treatment:

Behavioral: Module 2: Control of Reading Eye Movements

Behavioral: Module 3: Reading Practice with RSVP

Behavioral: Module 1: Visual Awareness and Eccentric Viewing

Group 3

Experimental group

Description:

The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 2 (Control of Reading Eye Movements)

Treatment:

Behavioral: Module 2: Control of Reading Eye Movements

Behavioral: Module 3: Reading Practice with RSVP

Behavioral: Module 1: Visual Awareness and Eccentric Viewing

Group 4

Experimental group

Description:

The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 2: Module 3 (Reading Practice with RSVP) Training Session 3: Module 2 (Control of Reading Eye Movements)

Treatment:

Behavioral: Module 2: Control of Reading Eye Movements

Behavioral: Module 3: Reading Practice with RSVP

Behavioral: Module 1: Visual Awareness and Eccentric Viewing

Group 5

Experimental group

Description:

The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 2 (Control of Reading Eye Movements) Training Session 2: Module 1 (Visual Awareness and Eccentric Viewing) Training Session 3: Module 3 (Reading Practice with RSVP)

Treatment:

Behavioral: Module 2: Control of Reading Eye Movements

Behavioral: Module 3: Reading Practice with RSVP

Behavioral: Module 1: Visual Awareness and Eccentric Viewing

Group 6

Experimental group

Description:

The subjects were trained in 6 weekly sessions of approximately 2 hours each, plus time for rest. This was followed by second assessments. The subjects were then trained on a second module for another 6 weeks, followed by third assessments. Finally, the subjects were trained on a third module for 6 weeks, followed by final assessments. Subjects in this group were trained according to the following counterbalanced module order: Training Session 1: Module 3 (Reading Practice with RSVP) Training Session 2: Module 2 (Control of Reading Eye Movements) Training Session 3: Module 1 (Visual Awareness and Eccentric Viewing)

Treatment:

Behavioral: Module 2: Control of Reading Eye Movements

Behavioral: Module 3: Reading Practice with RSVP

Behavioral: Module 1: Visual Awareness and Eccentric Viewing