GlaucomaNCT01669031
Randomized Controlled Trial on Visual Field Training
A study testing Practice program in people with Glaucoma, run by Oftalmologia Hospital Sotero del Rio at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Practice program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChile
- Study dates
- Aug 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients who cannot remain seated for 10 minutes
- patients with neck problems that prevent them from using the field analyzer properly
Trial locations and contacts
1 site in 1 country.
Eugenio Maul, MD/MPH contact
Chile1 site, 1 recruiting
- Recruiting
Hospital Sótero del Río
Santiago, Puente Alto
Eugenio A Maul, MD/MPH, +56 9 66593935, eugenio.maul@gmail.com
Militza Sanchez, CTO, +56 9 73927416, militza_a@hotmail.com
About this study
Official title: Effect of Exposure to Computer Simulated Visual Field Testing on Variability and Reliability of Test Results: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Practice program
- 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
- Medical subject headings
- Glaucoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice programOther
Also called Computer Simulated practice Visual Field Test
Each practice session (simulated visual field test on computer) takes 3-15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No practice tests are performed in this arm |
| Practice Program | Experimental | 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 Receives: Other: Practice program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute value of the difference in mean deviation of the first and second visual field exam
Measured: Visual field exams obtained 1 to 2 weeks apart
Secondary outcomes (4)
Difference in the absolute number of altered points in the visual field with a total deviation below the 0.5 percentile
Measured: Visual field exams obtained 1 to 2 weeks apart
Difference in the percentage of false positives, false negatives, and fixation losses at the first and second exam between control and intervention group
Measured: Visual field exams obtained 1 to 2 weeks apart
Difference in the time required to complete the first and second exam
Measured: Visual field exams obtained 1 to 2 weeks apart
Difference in the proportion of unreliable visual fields at the first and second exam between control and intervention groups
Measured: Visual field exams obtained 1 to 2 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oftalmologia Hospital Sotero del Rio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugenio A. Maul, Oftalmologia Hospital Sotero del Rio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669031
- Sponsor's protocol ID
- Oftalmo_Glaucoma_002
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exposure to Computer Simulated Visual Field Testing on Variability and Reliability of Test Results: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01669031
- Acronym / sponsor ID
- Oftalmo_Glaucoma_002
- Conditions
- Glaucoma
- Keywords
- automated perimetry, visual fields, reliability, vision tests/standards, randomized controlled trial, false positive reactions, false negative reactions, fixation, ocular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oftalmologia Hospital Sotero del RioUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No practice tests are performed in this arm |
| Practice Program | Experimental | Other: Practice programAt 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients who cannot remain seated for 10 minutes
- patients with neck problems that prevent them from using the field analyzer properly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practice programAlso: Computer Simulated practice Visual Field TestEach practice session (simulated visual field test on computer) takes 3-15 minutes | Other | Practice Program |
Primary outcome
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
4 secondary outcomes
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
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
Difference in the time required to complete the first and second exam
Time frame: Visual field exams obtained 1 to 2 weeks apart
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenio Maul, MD/MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice program in people with Glaucoma, run by Oftalmologia Hospital Sotero del Rio at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin B Hellman, Bachelors (67313177, justin@tentacle.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2012.