Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-12-29
2026-12-29
Brief Summary
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Detailed Description
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Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice. The eye is given topical fluorescein/anesthetic, the GAT prism contacts the eye while the observer looks through the slit lamp machine ocular using blue light illumination to visual the applanation mires. The GAT dial is adjusted until mire alignment is achieved and the IOP measurement is read off the GAT dial.
Pneumotonometer: This is what is done in routine eye care. You will receive a topical anesthetic (numbing agent). A probe will touch the front of the eye while the machine measures the eye pressure.
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 complementary metal oxide semiconductor (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. A similar method using an iPod touch camera has been previously published by this PI.
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.
The order of the above 4 measurements will be randomized.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Standard GAT
This is the gold-standard method for IOP measurement in clinical practice
Standard GAT
Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice
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
Fixed force GAT
An investigational device similar to standard GAT
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
Upright applanating prototype
An investigational device, prism used in standard and fixed-force GAT is attached to a portable device
Pneumotonometer
This is another standard method for IOP measurement in clinical practice
Pneumotonometer
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
Interventions
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Standard GAT
Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice
Fixed force GAT
An investigational device similar to standard GAT
Upright applanating prototype
An investigational device, prism used in standard and fixed-force GAT is attached to a portable device
Pneumotonometer
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
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years of age
* Able and willing to give consent
Exclusion Criteria
* Active infection of the eye
* Ocular surface trauma or infection
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Joanne Wen, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Eye Center
Locations
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Duke Eye Center
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Joanne Wen, MD
Role: primary
Other Identifiers
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Pro00106111_1
Identifier Type: -
Identifier Source: org_study_id