Randomized Controlled Trial on Visual Field Training

NCT01669031 | Unknown DMC

• 1 other identifier: Oftalmo_Glaucoma_002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• The absolute value of the difference in mean deviation of the first and second visual field exam

  Visual field exams obtained 1 to 2 weeks apart

Secondary Outcomes (4)

• Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentile

  Visual 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 group

  Visual field exams obtained 1 to 2 weeks apart

• Difference in the time required to complete the first and second exam

  Visual 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 groups

  Visual field exams obtained 1 to 2 weeks apart

Study Arms (2)

Control Group

NO INTERVENTION

No practice tests are performed in this arm

Practice Program

EXPERIMENTAL

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

Interventions

Practice program OTHER

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

Also known as: Computer Simulated practice Visual Field Test

Practice Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oftalmologia Hospital Sotero del Rio: lead

Study Sites (1)

Hospital Sótero del Río

Santiago, Puente Alto, Chile

RECRUITING

MeSH Terms

Conditions

Glaucoma; Disease

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Justin B Hellman, Bachelors

CONTACT

67313177; justin@tentacle.net

Eugenio Maul, MD/MPH

CONTACT

eugenio.maul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 20, 2012

Record last verified: 2012-08

Locations

CL (1)