Comparison of Visual Field Assessments Between Three Perimeters
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2024
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 6, 2024
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2025
CompletedResults Posted
Study results publicly available
April 30, 2026
CompletedApril 30, 2026
April 1, 2026
4 months
July 25, 2024
February 25, 2026
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total Acquisition Time (Both Eyes)
The total time to complete automated perimetry in both eyes.
Visit 1 (Day 0)
Secondary Outcomes (4)
Mean Deviation (MD)
Visit 1 (Day 0)
Pattern Standard Deviation (PSD)
Visit 1 (Day 0)
Foveal Threshold (FT)
Visit 1 (Day 0)
Patient Questionnaire
Visit 1 (Day 0)
Other Outcomes (2)
Visual Field Index (VFI)
Visit 1 (Day 0)
Setup Time
Visit 1 (Day 0)
Study Arms (3)
TEMPO
EXPERIMENTALVisual field assessment with the TEMPO
Humphrey Field Analyzer
ACTIVE COMPARATORVisual field assessment with the Humphrey Field Analyzer
VisuALL
ACTIVE COMPARATORVisual field assessment with the VisuALL
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients with best-corrected visual outcomes of 20/30 or better.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gainesville Eye Associateslead
- Sengicollaborator
Study Sites (1)
North Georgia Eye Associates
Gainesville, Georgia, 30501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clayton Blehm
- Organization
- North Georgia Eye Associates
Study Officials
- PRINCIPAL INVESTIGATOR
Clayton Blehm, MD
North Georgia Eye Associates
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
August 6, 2024
Study Start
November 18, 2024
Primary Completion
March 12, 2025
Study Completion
March 12, 2025
Last Updated
April 30, 2026
Results First Posted
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share