Rehabilitation of poor vision of neurological origin

ISRCTN	ISRCTN38035929
DOI	https://doi.org/10.1186/ISRCTN38035929
Secondary identifying numbers	N/A

Submission date: 16/02/2012
Registration date: 27/02/2012
Last edited: 08/12/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Visual impairment is a decreased ability to see to a degree that causes problems not fixable by usual means, such as glasses. There are about 180 million visually impaired people in the world. Visual impairment can be caused by defects in the eye or neurological problems in the nerves that carry information from the eye to the brain, where visual images are interpreted. The aim of this study is to test a new method of rehabilitation for low or poor vision.

Who can participate?
Patients with poor vision of neurological origin, aged over 18, living in Colombia, South America.

What does the study involve?
The study involves a new method of rehabilitation based on covering the healthy eye (i.e., the eye with better vision) and stimulating the eye with poor vision for periods of 5 hours daily for 10 days. The intensive stimulation is applied through a computer program and involves different kinds of stimuli, including discrimination of contrast and color, interpreting complex shapes, reading paragraphs with different font sizes, and perception of motion, speed and contour.

What are the possible benefits and risks of participating?
The potential benefit would be some degree of recovery of vision.

Where is the study run from?
Neurological Institute of Colombia.

When is the study starting and how long is it expected to run for?
June 2010 to June 2012.

Who is funding the study?
Neurological Institute of Colombia.

Who is the main contact?
José Iván Jiménez
direccion@neurologico.org.co

Contact information

Dr Jose Ivan Jimenez
Scientific

Neurological Institute of Colombia
Calle 55 No. 46-36
Medellin
-
Colombia

Phone	+57 4 5718178
Email	direccion@neurologico.org.co

Study information

Study design	Quasi-experimental clinical trial with intervention
Primary study design	Interventional
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Visual rehabilitation: brain plasticity or neuronal regeneration?
Study objectives	A 78 years old man presented an ischemic optic neuropathy of the right eye, leaving him with a vision of 20/200; this low vision remain stable for 6 years when he repeated ischemic optic neuropathy in the left eye, also producing low vision in that eye; the right eye, the affected first, recovered a lo of the loss of vision in the course of 2 or 3 months. Based on this observation we elaborate the hypothesis for this research which consists of a rehabilitation therapy based on the occlusion of the healthy eye or the eye with better vision for 5 hours daily for 2 weeks and submit the affected eye to an intensive optical functional occlusion therapy (OOF).
Ethics approval(s)	Neurological Institute of Colombia Ethics Committee, 09/03/2009
Health condition(s) or problem(s) studied	Low vision
Intervention	Patients who meet the criteria for inclusion and exclusion are intervened with occlusion of the normal or better eye and an intensive visual stimulation procedure for periods of 5 hours daily for 10 days. The intensive visual stimulation is applied through a computer program, with stimuli of different kinds, such as discrimination of contrast, color vision, interpretation of complex shapes, reading paragraphs with different font sizes, perception of motion, speed and contour etc. fMRI and visual evoked potentials are also performed. All this test are realized before and after intervention
Intervention type	Other
Primary outcome measure	Comparison of tests before and after intervention will permit the evalution of the results
Secondary outcome measures	Changes in activation of cortical visual areas by functional magnetic resonance
Overall study start date	30/06/2010
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Age greater than or equal to 18 2. Isquemic optic neuropathy 3. Optic neuropathy by Multiple Sclerosis 4. Amblyopia secondary to strabismus 5. Traumatic optic neuropathy 6. At least one year of evolution of the previous conditions 7. Alteration of unilateral or bilateral visual acuity, defined as unilateral or bilateral visual acuity less than 20/60 8. In case of bilateral involvement, there should be an eye with better visual acuity, still below the 20/60 9. The visually impaired should have some stability over time, without clinical signs of improvement, even with the best possible optical correction or intervention 10. Clinical condition equivalent to a diagnosis of low vision
Key exclusion criteria	1. Visual deficit bilaterally and in the same visual range 2. Optic Atrophy of nonspecific of uncertain origin 3. Optical refractive errors 4. Low vision of ophthalmic pathology: glaucoma, sequelae of retinopathy of prematurity, hypertensive retinopathy, diabetic retinopathy, cataract, retinitis pigmentosa and macular degeneration associated with age 5. Presence of tumor disease of the optic nerve 6. Intensive therapy with steroids in the last 6 months 7. Relapsed Acute optic neuritis type in the last 6 months 8. Lack of ability to understand instructions and adhere to intervention
Date of first enrolment	30/06/2010
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Colombia

Study participating centre

Neurological Institute of Colombia

Medellin
-
Colombia

Sponsor information

Neurological Institute of Colombia (Colombia)
Research organisation

Calle 55 No. 46-36
Medellin
-
Colombia

Phone	+57 4 5718178
Email	direccion@neurologico.org.co
Website	http://www.neurologico.org.co
"ROR"	https://ror.org/00fsjhf77

Funders

Funder type

Research organisation

Neurological Institute of Colombia, Medellín (Colombia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan