Automated Applanation Tonometry - Updated

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07298356
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard GAT — DEVICE
    Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice
  • Fixed force GAT — DEVICE
    An investigational device similar to standard GAT
  • Upright applanating prototype — DEVICE
    An investigational device, prism used in standard and fixed-force GAT is attached to a portable device
  • Pneumotonometer — DEVICE
    This is a standard for checking eye pressure. A topical anesthetic (numbing agent). A probe will touch the front of the eye while the machine measures the eye pressure

Study Details

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. Another clinical standard for checking eye pressure is known as the pneumotonometer. This method is more objective but not portable. The purpose of this study is to develop new methods of measuring eye pressure that are more objective, reproducible and portable. In this study, the investigators will be comparing the eye pressure measurements using 2 investigational methods to GAT and pneuumotonometer.

Key Dates

Start date
Mar 2, 2026
Status verified
Dec 2025
Primary completion
Dec 29, 2026
Completion
Dec 29, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Standard GAT
    This is the gold-standard method for IOP measurement in clinical practice
  • Experimental: Fixed-force GAT
    From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein/anesthetic. The GAT dial is set at 1.8 or 2.0, a C-MOS camera is connected to one of the oculars of the slit lamp machine and under blue light illumination, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance through the ocular. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter
  • Experimental: Upright applanating prototype
    With this prototype, an applanating prism (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is attached to a fixed-force spring that creates a force equivalent to 1.8 or 2.0 on the GAT dial. Blue LED lights on the prototype are used to create the blue illumination similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. A C-MOS camera is aligned with the GAT prism to image the applanation mires. The eye is given topical fluorescein/anesthetic. Like fixed-force GAT, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter
  • Active Comparator: Pneumotonometer
    This is another standard method for IOP measurement in clinical practice

Primary Outcome Measure

Intraocular pressure (IOP) as measured by standard GAT [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Eye CenterDurhamNorth Carolina27710
Joanne Wen, MD
[email protected]
919-684-2975
Joanne Wen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Duke Eye Center· Durham, NC

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