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TEMPO for Glaucoma
Phase 4
Waitlist Available
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
* Adult patients with best-corrected visual outcomes of 20/30 or better.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (day 0)
Awards & highlights
Summary
A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, 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
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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.Primary study objectives
Total acquisition time (both eyes)
Secondary study objectives
Foveal threshold (FT)
Mean deviation (MD)
Patient questionnaire
+1 moreOther study objectives
False positives and false negatives (frequency)
Setup time
Visual field index (VFI)
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
24 Previous Clinical Trials
1,795 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
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