Comparison of Visual Field Assessments Between Three Perimeters
Phase 4
Completed
- Conditions
- Glaucoma
- Interventions
- Diagnostic Test: Visual field assessment
- Registration Number
- NCT06539715
- Lead Sponsor
- Gainesville Eye Associates
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Adult patients with best-corrected visual outcomes of 20/30 or better.
Exclusion Criteria
- Unable to tolerate ophthalmic imaging
- Any ocular or systemic conditions, that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TEMPO Visual field assessment Visual field assessment with the TEMPO Humphrey Field Analyzer Visual field assessment Visual field assessment with the Humphrey Field Analyzer VisuALL Visual field assessment Visual field assessment with the VisuALL
- Primary Outcome Measures
Name Time Method Total acquisition time (both eyes) Visit 1 (Day 0)
- Secondary Outcome Measures
Name Time Method Pattern standard deviation (PSD) Visit 1 (Day 0) PSD is a measure of visual field irregularity.
Foveal threshold (FT) Visit 1 (Day 0) FT provides an estimate for best-corrected visual acuity.
Mean deviation (MD) Visit 1 (Day 0) Patient questionnaire Visit 1 (Day 0) A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) to assess comfort, ease of use, and anxiety with each device.
Trial Locations
- Locations (1)
North Georgia Eye Associates
🇺🇸Gainesville, Georgia, United States