MedPath

Comparison of Visual Field Assessments Between Three Perimeters

Phase 4
Completed
Conditions
Glaucoma
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
Primary Outcome Measures
NameTimeMethod
Total acquisition time (both eyes)Visit 1 (Day 0)
Secondary Outcome Measures
NameTimeMethod
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 questionnaireVisit 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

North Georgia Eye Associates
🇺🇸Gainesville, Georgia, United States
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