Randomized Controlled Trial on Visual Field Training
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Other: Practice program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Effect of Exposure to Computer Simulated Visual Field Testing on Variability and Reliability of Test Results: A Randomized Controlled Trial |
- The absolute value of the difference in mean deviation of the first and second visual field exam [ Time Frame: Visual field exams obtained 1 to 2 weeks apart ] [ Designated as safety issue: No ]
- Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentile [ Time Frame: Visual field exams obtained 1 to 2 weeks apart ] [ Designated as safety issue: No ]
- Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention group [ Time Frame: Visual field exams obtained 1 to 2 weeks apart ] [ Designated as safety issue: No ]
- Difference in the time required to complete the first and second exam [ Time Frame: Visual field exams obtained 1 to 2 weeks apart ] [ Designated as safety issue: No ]
- Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groups [ Time Frame: Visual field exams obtained 1 to 2 weeks apart ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control Group
No practice tests are performed in this arm
|
|
|
Experimental: Practice Program
At the 3 study visits exposed to a training session (simulated visual field test on a computer). Visit 1 they get 2 simulated tests tests per eye. At visits 2 and 3 they get 1 simulated test per eye. Each simulated test takes 3-15 minutes |
Other: Practice program
Each practice session (simulated visual field test on computer) takes 3-15 minutes
Other Name: Computer Simulated practice Visual Field Test
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Justin B Hellman, Bachelors | 67313177 | justin@tentacle.net |
| Contact: Eugenio Maul, MD/MPH | eugenio.maul@gmail.com |
| Chile | |
| Hospital Sótero del Río | Recruiting |
| Santiago, Puente Alto, Chile | |
| Contact: Eugenio A Maul, MD/MPH +56 9 66593935 eugenio.maul@gmail.com | |
| Contact: Militza Sanchez, CTO +56 9 73927416 militza_a@hotmail.com | |
| Principal Investigator: Eugenio A Maul, MD MPH | |
| Sub-Investigator: Jimena Schmidt, MD | |
| Sub-Investigator: Andres Gerhard, MD | |
More Information
No publications provided
| Responsible Party: | Eugenio A. Maul, Investigator, Oftalmologia Hospital Sotero del Rio |
| ClinicalTrials.gov Identifier: | NCT01669031 History of Changes |
| Other Study ID Numbers: | Oftalmo_Glaucoma_002 |
| Study First Received: | August 16, 2012 |
| Last Updated: | August 16, 2012 |
| Health Authority: | Chile: Marcelo Coria, Jefe de Servicio de Oftalmologia, Hospital Sotero del Rio. |
Keywords provided by Oftalmologia Hospital Sotero del Rio:
|
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 |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013