A Multi-Center Study of Reading Rehabilitation in Macular Disease

NCT00746668 | Completed Results

• 1 other identifier: C6246-R
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age Related Maculopathy; Retinal Degeneration

Keywords

Reading; Macular Degeneration; Rehabilitation; Vision, Low

Outcome Measures

Primary Outcomes (1)

• Sentence Reading

  To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).

  Pre-training, 6 weeks, 12 weeks, 18 weeks

Study Arms (7)

Control Group

EXPERIMENTAL

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.

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

Group 1

EXPERIMENTAL

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)

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

Group 2

EXPERIMENTAL

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)

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

Group 3

EXPERIMENTAL

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)

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

Group 4

EXPERIMENTAL

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)

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

Group 5

EXPERIMENTAL

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)

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

Group 6

EXPERIMENTAL

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)

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

Interventions

Module 1: Visual Awareness and Eccentric Viewing BEHAVIORAL

In this module, awareness of the PRL location and eccentric viewing were trained. Exercises based on published sources were administered. One example of these exercises is the clock face display adapted from Holcomb and Goodrich and Maplesden. This module also focused on awareness of the perceptual consequences of using a PRL. The purpose of these training exercises was to allow the subjects to appreciate perceptual alterations that occur when using a PRL and to practice making perceptual discriminations with the peripheral retina. Previously published work has demonstrated that perception in the peripheral retina can be affected by practice.

Control Group; Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Module 2: Control of Reading Eye Movements BEHAVIORAL

In this module, control of eye movements was trained. These exercises began with a series of saccade tasks to nonalphabetical stimuli and then progressed to single letter, letter pairs, and word stimuli. Subjects were instructed to make a saccade between the dots. The experimenter provided feedback concerning the appropriateness of the saccades, and the alternation rate of the dots was increased as performance improved.

Control Group; Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Module 3: Reading Practice with RSVP BEHAVIORAL

In module 3, we wanted to assess only the higher-level effects of reading practice. Subjects practiced reading using stimuli that did not require reading eye movements. An example is short sentences that were presented one word at a time at a single location on a screen (Rapid Serial Visual Presentation \[RSVP\]). At the end of the sentence, subjects reported whether the sentence made sense or not. We also had our subjects practice reading scrolled text. Although, eye movements and saccades may spontaneously occur under the text presentation conditions of this module, they are not the efficient saccades necessary for reading.

Also known as: Sequential Presentation of Lexical Information

Control Group; Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Jesse Brown VAMC (WestSide Division)

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Retinal Degeneration; Vision, Low

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Janet P. Szlyk, PhD
• Organization: Jesse Brown VAMC

Janet.Szlyk@va.gov

312-997-3644

Study Officials

• Janet P Szlyk, PhD

  Jesse Brown VAMC (WestSide Division)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 27, 2015
• Results First Posted: February 27, 2015

Record last verified: 2015-02

Locations

US (1)