Randomized Controlled Trial on Visual Field Training

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01669031
• Other study ID #: Oftalmo_Glaucoma_002
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2012
• Last updated: August 16, 2012
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2012
• Source: Oftalmologia Hospital Sotero del Rio
• Contact: Justin B Hellman, Bachelors
• Phone: 67313177
• Email: justin[@]tentacle.net
• Is FDA regulated: No
• Health authority: Chile: Marcelo Coria, Jefe de Servicio de Oftalmologia, Hospital Sotero del Rio.
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma

Intervention

Other:
• Practice program
Each practice session (simulated visual field test on computer) takes 3-15 minutes

Locations

Country	Name	City	State
Chile	Hospital Sótero del Río	Santiago	Puente Alto

Sponsors (1)

Lead Sponsor	Collaborator
Oftalmologia Hospital Sotero del Rio

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Difference in the time required to complete the first and second exam		Visual field exams obtained 1 to 2 weeks apart	No
Secondary	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	No