Brain Injuries, Traumatic Clinical Trial
NCT number | NCT04043429 |
Other study ID # | VRT100 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2003 |
Est. completion date | January 2005 |
Verified date | July 2019 |
Source | University of Magdeburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.
Status | Completed |
Enrollment | 86 |
Est. completion date | January 2005 |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Visual field defects after brain damage - lesion age above 6 months - documented brain lesions due to ischemic stroke, hemorrhage or tumor demonstrated by computer tomography or by magnet resonance imaging Exclusion Criteria: - hemispatial neglect - complete blindness - severe psychotic diseases - serious drug abuse - chronic degenerative diseases (dementia, multiple sclerosis) - severe motor impairments - noticeable low intelligence influencing proper comprehension of diagnostic and training instructions - considerable impaired vision (visual acuity below 0.1 generated by amblyopia, opacity of cornea or lens, maculopathy and other retinal diseases where vision impairment is expected in the next month (e.g. subretinal neovascularisation, retinitis pigmentosa, diabetic retinopathy) - inability to fixate due to central scotoma, pathological nystagmus or other forms of fixation disabilities |
Country | Name | City | State |
---|---|---|---|
Germany | Inst. f. Medical Psychology, Univ. of Magdeburg | Magdeburg |
Lead Sponsor | Collaborator |
---|---|
University of Magdeburg |
Germany,
Sabel BA, Gudlin J. Vision restoration training for glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2014 Apr 1;132(4):381-9. doi: 10.1001/jamaophthalmol.2013.7963. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | High Resolution Perimetry - Detectection performance change before vs. after training (%) | 3 months | ||
Primary | Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%) | 3 months |
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