Randomized Controlled Trial on Visual Field Training

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Oftalmologia Hospital Sotero del Rio.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eugenio A. Maul, Oftalmologia Hospital Sotero del Rio
ClinicalTrials.gov Identifier:
NCT01669031
First received: August 16, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Oftalmologia Hospital Sotero del Rio:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669031

Contacts
Contact: Justin B Hellman, Bachelors 67313177 justin@tentacle.net
Contact: Eugenio Maul, MD/MPH eugenio.maul@gmail.com

Locations
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         
Sponsors and Collaborators
Oftalmologia Hospital Sotero del Rio
  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 September 14, 2014