Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multi-Center Study of Reading Rehabilitation in Macular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00746668
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor)
Conditions Age Related Maculopathy
Retinal Degeneration
Interventions Behavioral: Module 1: Visual Awareness and Eccentric Viewing
Behavioral: Module 2: Control of Reading Eye Movements
Behavioral: Module 3: Reading Practice with RSVP
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Group 1 Group 2 Group 3 Group 4 Group 5 Group 6
Hide Arm/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.

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)

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)

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)

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)

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)

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)

Period Title: Overall Study
Started 6 5 5 5 5 5 5
Completed 6 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All subjects' reading performances were initially assessed before training began. Reading performance were assessed using sentences displayed on a computer monitor. Two lines of text were presented at the center of the monitor with each subject seated 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.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  44.4%
>=65 years
20
  55.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
19
  52.8%
Male
17
  47.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Sentence Reading
Hide Description 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).
Time Frame Pre-training, 6 weeks, 12 weeks, 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Arm 1: Pre-Training Arm 2: Assessment After Module 1 Arm 3: Assessment After Module 2 Arm 4: Assessment After Module 3
Hide Arm/Group Description:
Baseline Assessment prior to training.
Assessment after six-weeks of training in Module 1 (PRL Awareness Training).
Assessment after six-weeks of training in Module 2 (Eye Movement Training).
Assessment after six-weeks of training in Module 3 (RSVP Reading).
Overall Number of Participants Analyzed 30 30 30 30
Mean (Standard Deviation)
Unit of Measure: Words per Minute (wpm)
58.9  (0.00) 50.5  (7.2) 86.2  (6.8) 49.1  (7.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Group 1 Group 2 Group 3 Group 4 Group 5 Group 6
Hide Arm/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.

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)

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)

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)

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)

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)

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)

All-Cause Mortality
Control Group Group 1 Group 2 Group 3 Group 4 Group 5 Group 6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Group 1 Group 2 Group 3 Group 4 Group 5 Group 6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Group 1 Group 2 Group 3 Group 4 Group 5 Group 6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Janet P. Szlyk, PhD
Organization: Jesse Brown VAMC
Phone: 312-997-3644
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00746668     History of Changes
Other Study ID Numbers: C6246-R
First Submitted: September 3, 2008
First Posted: September 4, 2008
Results First Submitted: December 22, 2014
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015