Randomized Controlled Trial on Visual Field Training

Oftalmologia Hospital Sotero del Rio

Status: Unknown

Conditions: Glaucoma

Treatments: Other: Practice program

Study type: Interventional

Funder types: Other

Identifiers

NCT01669031

Oftalmo_Glaucoma_002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Control Group

No Intervention group

Description:

No practice tests are performed in this arm

Practice Program

Experimental group

Description:

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

Treatment:

Other: Practice program