Automated Applanation Tonometry
NCT05235321 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111
Last updated 2025-06-13
Summary
Goldmann Applanation Tonometry (GAT) is considered the clinical gold standard for eye pressure measurements and yet it is known to be a subjective measurement with limited repeatability and limited portability. The purpose of this study is to develop an automated and objective method for performing applanation tonometry using standard ophthalmic equipment as well as using 2 portable prototypes.
Conditions
- Glaucoma
- Glaucoma, Suspect
Interventions
- DEVICE
-
Standard GAT
Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice
- DEVICE
-
Fixed force GAT
An investigational device similar to standard GAT
- DEVICE
-
Upright applanating prototype
An investigational device, prism used in standard and fixed-force GAT is attached to a portable device
- DEVICE
-
Supine Applanating Prototype
An investigational device, prism used in standard and fixed-force GAT is attached to a portable device performed in the supine position
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Joanne Wen, MD · Duke Eye Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-21
- Primary Completion
- 2024-05-31
- Completion
- 2024-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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