Glaucoma
Conditions
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.
Interventions
DIAGNOSTIC_TESTVisual field assessment
Automated perimetry
Sponsors
Gainesville Eye Associates
Sengi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Acquisition Time (Both Eyes) | Visit 1 (Day 0) | The total time to complete automated perimetry in both eyes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Deviation (MD) | Visit 1 (Day 0) | visual field mean deviation (unit = decibels) |
| Pattern Standard Deviation (PSD) | Visit 1 (Day 0) | visual field pattern standard deviation (unit = decibels) PSD is a measure of visual field irregularity. |
| Foveal Threshold (FT) | Visit 1 (Day 0) | visual field foveal threshold (unit = decibels) |
| Patient Questionnaire | Visit 1 (Day 0) | A series of 9 Likert style questions (Strongly Disagree to Strongly Agree) that patients answered about the comfort, ease of use, and anxiety with each device. Strongly Agree was considered a better outcome for comfort and ease of use questions, and Strongly Disagree was considered a better outcome for anxiety questions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClayton Blehm, MD
North Georgia Eye Associates
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 54 | 0 / 54 |
| other Total, other adverse events | 0 / 54 | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 | 0 / 54 |
Outcome results
None listed