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Randomized Controlled Trial on Visual Field Training

NCT ID: NCT01669031

Last Updated: 2012-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Glaucoma

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

No practice tests are performed in this arm

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Practice program

Intervention Type OTHER

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

Interventions

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Practice program

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

Intervention Type OTHER

Other Intervention Names

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Computer Simulated practice Visual Field Test

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oftalmologia Hospital Sotero del Rio

OTHER

Sponsor Role lead

Responsible Party

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Eugenio A. Maul

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Sótero del Río

Santiago, Puente Alto, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Justin B Hellman, Bachelors

Role: CONTACT

Phone: 67313177

Email: [email protected]

Eugenio Maul, MD/MPH

Role: CONTACT

Email: [email protected]

Facility Contacts

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Eugenio A Maul, MD/MPH

Role: primary

Militza Sanchez, CTO

Role: backup

Other Identifiers

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Oftalmo_Glaucoma_002

Identifier Type: -

Identifier Source: org_study_id