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Randomized Controlled Trial on Visual Field Training

Primary Purpose

Glaucoma

Status

Unknown status

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Practice program

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Sótero del RíoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Practice Program

Arm Description

No practice tests are performed in this arm

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention group

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

Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groups

Full Information

NCT ID

NCT01669031

First Posted

August 16, 2012

Last Updated

August 16, 2012

Sponsor

Oftalmologia Hospital Sotero del Rio

1. Study Identification

Unique Protocol Identification Number

NCT01669031

Brief Title

Randomized Controlled Trial on Visual Field Training

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oftalmologia Hospital Sotero del Rio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

No practice tests are performed in this arm

Arm Title

Practice Program

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Practice program

Other Intervention Name(s)

Computer Simulated practice Visual Field Test

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame