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Randomized Controlled Trial on Visual Field Training

Effect of Exposure to Computer Simulated Visual Field Testing on Variability and Reliability of Test Results: A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01669031
Enrollment
200
Registered
2012-08-20
Start date
2012-08-31
Completion date
2013-05-31
Last updated
2012-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERPractice program

Each practice session (simulated visual field test on computer) takes 3-15 minutes

Sponsors

Oftalmologia Hospital Sotero del Rio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The absolute value of the difference in mean deviation of the first and second visual field examVisual field exams obtained 1 to 2 weeks apart

Secondary

MeasureTime frame
Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentileVisual field exams obtained 1 to 2 weeks apart
Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention groupVisual field exams obtained 1 to 2 weeks apart
Difference in the time required to complete the first and second examVisual field exams obtained 1 to 2 weeks apart
Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groupsVisual field exams obtained 1 to 2 weeks apart

Countries

Chile

Contacts

Primary ContactJustin B Hellman, Bachelors
justin@tentacle.net67313177
Backup ContactEugenio Maul, MD/MPH
eugenio.maul@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026