Retinal Degeneration Clinical Trial
Official title:
A Multi-Center Study of Reading Rehabilitation in Macular Disease
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01432847 -
Cell Collection to Study Eye Diseases
|
||
Terminated |
NCT03561922 -
Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
|
N/A | |
Active, not recruiting |
NCT03872479 -
Single Ascending Dose Study in Participants With LCA10
|
Phase 1/Phase 2 | |
Completed |
NCT00231010 -
Molecular Genetics of Retinal Degenerations
|
||
Recruiting |
NCT03078309 -
The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients
|
Early Phase 1 | |
Active, not recruiting |
NCT01736293 -
Natural History of Eye Diseases Related to ABCA4 Mutations
|
||
Completed |
NCT03318549 -
BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
|
N/A | |
Completed |
NCT04919473 -
Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis Pigmentosa
|
Phase 1/Phase 2 | |
Completed |
NCT03321253 -
Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification
|
N/A | |
Completed |
NCT01497379 -
Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
|
N/A | |
Recruiting |
NCT04620876 -
Bimodal and Coaxial High Resolution Ophtalmic Imaging
|
N/A | |
Recruiting |
NCT03592017 -
Performance of Long-wavelength Autofluorescence Imaging
|
N/A | |
Completed |
NCT03150654 -
The Effect of Laser Treatment on Macular Pigment of Eye in Cases With Diabetes
|
N/A | |
Recruiting |
NCT04545736 -
Oral Metformin for Treatment of ABCA4 Retinopathy
|
Phase 1/Phase 2 | |
Completed |
NCT00403195 -
Clinical and Pathophysiological Description of Ocular Ischemic Syndrome
|
N/A | |
Enrolling by invitation |
NCT06167642 -
Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
|
||
Enrolling by invitation |
NCT02144103 -
Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Glaucomatous Neurodegeneration
|
Phase 1/Phase 2 | |
Recruiting |
NCT06289452 -
Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis
|
Early Phase 1 | |
Recruiting |
NCT06305416 -
A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema
|
Phase 3 | |
Recruiting |
NCT02617966 -
Rod and Cone Mediated Function in Retinal Disease
|