New Eye Pressure Measurement Methods for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods for measuring eye pressure in people with glaucoma, aiming for more accurate and portable solutions. It compares two new methods, including the Upright applanating prototype, with established tools like the Goldmann Applanation Tonometry and pneumotonometer. Individuals undergoing routine eye exams without eye infections or corneal scars might be suitable candidates. The goal is to discover a better way to monitor eye pressure, aiding in effective glaucoma management. As an unphased trial, this study allows participants to contribute to innovative research that could enhance glaucoma management.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on eye pressure measurement methods, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.
What prior data suggests that these new eye pressure measurement methods are safe?
Research has shown that the treatments tested in this trial have been safe in similar studies. The new device functions like other methods that people usually handle well. Although direct safety data for this exact device is unavailable, similar devices have been safely used in other studies on eye pressure.
The fixed-force GAT method resembles the standard Goldmann Applanation Tonometry (GAT), a safe and common eye test. This method uses eye drops to numb the eye, and these drops are generally well-tolerated.
Overall, both methods are based on techniques already used safely, suggesting they are likely safe for people. However, those considering joining the trial should discuss any concerns with their doctor.12345Why are researchers excited about this trial?
Researchers are excited about the new upright applanating prototype for measuring eye pressure in glaucoma patients because it offers a potentially more convenient and equally accurate alternative to traditional methods. Unlike the gold-standard Goldmann Applanation Tonometry (GAT), this prototype uses an innovative design with a custom-made prism and a fixed-force spring, which can simplify the procedure. Additionally, it incorporates modern technology like blue LED lights and a C-MOS camera to accurately capture and calculate intraocular pressure (IOP) through video imaging. This could lead to more efficient and accessible IOP measurements, which are crucial for effectively managing glaucoma.
What evidence suggests that these new eye pressure measurement methods are effective for glaucoma?
Research has shown that measuring eye pressure is crucial for managing glaucoma, a major cause of vision loss. This trial evaluates a new upright applanating prototype designed to measure eye pressure accurately and be easily portable, enhancing glaucoma diagnosis. Although detailed human data is limited, the device aims to match the accuracy of current top methods like Goldmann Applanation Tonometry (GAT) while offering greater portability. Another arm of the trial will assess the fixed-force GAT, which previous studies found to provide results similar to the standard GAT, indicating it could reliably check eye pressure. Both methods may offer more consistent and portable options for monitoring eye pressure.23678
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
Citations
How to Measure Intraocular Pressure: An Updated Review of ...
When compared to gold standard GAT, clinical results report a good correlation of tonometry readings, with r values greater than 0.8 for low-to-moderate GAT ...
Review article Intraocular pressure measurement: A review
The Goldmann applanation tonometer is acknowledged as the gold standard for IOP measurement based on the Imbert-Fick law, which assumes that the pressure within ...
Agreement of patient-measured intraocular pressure using ...
There were 45.5% (70 out of 154) of IOP measurements by GAT were higher than that by rebound tonometry. There was no significant difference in ...
New Eye Pressure Measurement Methods for Glaucoma
The study tests two new methods of measuring eye pressure against the current standards: Goldmann Applanation Tonometry (GAT) and pneumotonometer. The goal ...
5.
researchgate.net
researchgate.net/publication/340945773_Using_Deep_Learning_to_Automate_Goldmann_Applanation_Tonometry_ReadingsUsing Deep Learning to Automate Goldmann Applanation ...
Each eye was measured by two observers, resulting in 100 videos. Within the test set, the mean difference between automated and standard GAT was -0.9 mmHg with ...
Automated Applanation Tonometry - Updated
Goldmann Applanation Tonometry (GAT) is considered the clinical gold standard for eye pressure measurements and yet it is known to be a ...
Long-term Safety and Performance of a Suprachoroidal ...
The primary performance end point was to evaluate the limits of agreement between measurements with the EYEMATE-SC and Goldmann applanation tonometry (GAT) from ...
Smartphone Tonometer Effective in Measuring IOP
It uses fixed force applanation in conjunction with a machine-learning computer algorithm to calculate IOP. For this proof of concept study, the ...
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