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Visual Field Assessment for Glaucoma
Phase 4
Recruiting
Led By Clayton Blehm, MD
Research Sponsored by Gainesville Eye Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
History of any ocular or systemic conditions that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (day 0)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares three different machines used for assessing visual fields. Participants will have one visit where they will be tested on various parameters including visual field, optic nerve imaging, and a questionnaire.
Who is the study for?
This trial is for individuals with glaucoma who are able to visit the study center for an assessment. Specific eligibility details aren't provided, but typically participants would need to meet certain health criteria and be willing to undergo various tests as part of the study.
What is being tested?
The trial is comparing visual field assessments using three different perimeters: TEMPO, VisuALL, and HFA. It's a single-visit study where subjects will have their vision fields tested by these devices to see which gives the best results.
What are the potential side effects?
Since this trial involves non-invasive visual field assessments, there are no direct side effects associated with the interventions being studied.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I don't have eye conditions like severe glaucoma that could affect vision tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 1 (day 0)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (day 0)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Foveal threshold (FT)
Patient questionnaire
Pattern standard deviation (PSD)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: TEMPOExperimental Treatment1 Intervention
Visual field assessment with the TEMPO
Group II: Humphrey Field AnalyzerActive Control1 Intervention
Visual field assessment with the Humphrey Field Analyzer
Group III: VisuALLActive Control1 Intervention
Visual field assessment with the VisuALL
Find a Location
Who is running the clinical trial?
Gainesville Eye AssociatesLead Sponsor
6 Previous Clinical Trials
287 Total Patients Enrolled
SengiIndustry Sponsor
25 Previous Clinical Trials
1,959 Total Patients Enrolled
1 Trials studying Glaucoma
100 Patients Enrolled for Glaucoma
Clayton Blehm, MDPrincipal InvestigatorNorth Georgia Eye Associates
2 Previous Clinical Trials
49 Total Patients Enrolled