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

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Other: Practice program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justin B Hellman, Bachelors; Phone Number: 67313177; Email: justin@tentacle.net
• Study Contact Backup: Name: Eugenio Maul, MD/MPH; Email: eugenio.maul@gmail.com

Study Locations

• Chile
  • Puente Alto
    • Santiago, Puente Alto, Chile
      • Recruiting
      • Hospital Sotero del Rio
      • Principal Investigator: Eugenio A Maul, MD MPH
      • Contact: Eugenio A Maul, MD/MPH; Phone Number: +56 9 66593935; Email: eugenio.maul@gmail.com
      • Contact: Militza Sanchez, CTO; Phone Number: +56 9 73927416; Email: militza_a@hotmail.com
      • Sub-Investigator: Jimena Schmidt, MD
      • Sub-Investigator: Andres Gerhard, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Computer Simulated practice Visual Field Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Oftalmologia Hospital Sotero del Rio

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2012
• Last Update Submitted That Met QC Criteria: August 16, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: randomized controlled trial; male; program; female; aged; reliability; humans; variability; software; prospective studies; visual fields; automated perimetry; vision tests/standards; false positive reactions; false negative reactions; fixation, ocular; mean deviation; glaucoma/diagnosis; visual field tests/methods; reproducibility of results
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Oftalmo_Glaucoma_002