Clinical trial NCT01669031: Randomized Controlled Trial on Visual Field Training
Official title: Effect of Exposure to Computer Simulated Visual Field Testing on Variability and Reliability of Test Results: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: automated perimetry
visual fields
reliability
vision tests/standards
randomized controlled trial
false positive reactions
false negative reactions
fixation, ocular
mean deviation
variability
program
software
glaucoma/diagnosis
visual field tests/methods
aged
humans
female
male
prospective studies
reproducibility of results
Lead sponsor: Oftalmologia Hospital Sotero del Rio
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Unreliability and visual field variability is a known problem with automated perimetry in both developing and developed country settings. This study will look at the effects of a computer program that allows new patients to practice the visual field exam before taking the actual exam. Our hypothesis is that the intervention group will have less variability as measured by mean deviation between exams and greater reliability as measured by the standard unreliability indexes of false positive rate, false negative rate, and fixation losses.

Detailed description: 3 study visits. Visit 1: Baseline visit for consent, getting baseline data and finally randomizing the patient. Those randomized to intervention get their first session of simulated visual field (2 per eye) on a regular computer for training purposes.

Visit 2: 1 to 2 days after baseline. The intervention group gets 1 practice test per eye. Then both groups get a regular automated visual field Visit 3: 1 to 2 weeks after baseline. The intervention group gets 1 practice test per eye. Then both groups get a regular automated visual field.

Study Ends, patient gets seen by the patient.

Eligibility criteria: Inclusion Criteria:

* 18 years old or greater
* Referred to the glaucoma clinic for examination due to suspected glaucoma or glaucoma diagnosis
* No more than 1 automated visual field test within the last 4 years

Exclusion Criteria:

* patients who cannot remain seated for 10 minutes
* patients with neck problems that prevent them from using the field analyzer properly

Primary outcomes:
measure: The absolute value of the difference in mean deviation of the first and second visual field exam
timeFrame: Visual field exams obtained 1 to 2 weeks apart
Secondary outcomes:
measure: Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentile
timeFrame: Visual field exams obtained 1 to 2 weeks apart
measure: Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention group
timeFrame: Visual field exams obtained 1 to 2 weeks apart
measure: Difference in the time required to complete the first and second exam
timeFrame: Visual field exams obtained 1 to 2 weeks apart
measure: Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groups
timeFrame: Visual field exams obtained 1 to 2 weeks apart
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Sótero del Río
state: Puente Alto
Study officials:
References: