New Eye Pressure Measurement Methods for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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, we will be comparing the eye pressure measurements using 2 investigational methods to GAT and pneuumotonometer.
Who Is on the Research Team?
Joanne Wen, MD
Principal Investigator
Duke Eye Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are able to consent and are coming in for a routine eye exam. It's focused on those with glaucoma or ocular hypertension, looking to find more reliable and portable ways to measure eye pressure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Measurement
Intraocular pressure (IOP) measurements are taken using standard GAT, pneumotonometer, fixed-force GAT, and upright applanating prototype
Follow-up
Participants are monitored for any adverse effects and the effectiveness of the measurement methods
What Are the Treatments Tested in This Trial?
Interventions
- Upright applanating prototype
Trial Overview
The study tests two new methods of measuring eye pressure against the current standards: Goldmann Applanation Tonometry (GAT) and pneumotonometer. The goal is to see if these new methods are more objective, repeatable, and easier to use.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
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
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
This is another standard method for IOP measurement in clinical practice
This is the gold-standard method for IOP measurement in clinical practice
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
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