Condition category
Ear, Nose and Throat
Date applied
16/02/2012
Date assigned
27/02/2012
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Ivan Jimenez

ORCID ID

Contact details

Neurological Institute of Colombia
Calle 55 No. 46-36
Medellin
-
Colombia
+57 4 5718178
direccion@neurologico.org.co

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Visual rehabilitation: brain plasticity or neuronal regeneration?

Acronym

Study hypothesis

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

Neurological Institute of Colombia Ethics Committee, 09/03/2009

Study design

Quasi-experimental clinical trial with intervention

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

30/06/2010

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

30/06/2010

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Colombia

Trial participating centre

Neurological Institute of Colombia
Medellin
-
Colombia

Sponsor information

Organisation

Neurological Institute of Colombia (Colombia)

Sponsor details

Calle 55 No. 46-36
Medellin
-
Colombia
+57 4 5718178
direccion@neurologico.org.co

Sponsor type

Research organisation

Website

http://www.neurologico.org.co

Funders

Funder type

Research organisation

Funder name

Neurological Institute of Colombia, Medellín (Colombia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes