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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2019
Source University of Magdeburg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Vision Restoration Training (VRT)

Vision Exploration Training (VET)


Locations

Country Name City State
Germany Inst. f. Medical Psychology, Univ. of Magdeburg Magdeburg

Sponsors (1)

Lead Sponsor Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

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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