Automated Applanation Tonometry

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Glaucoma, Suspect
• Intervention / Treatment: Device: Standard GAT; Device: Fixed force GAT; Device: Upright applanating prototype; Device: Supine Applanating Prototype

Detailed Description

This is a prospective study. Patients presenting for their scheduled eye appointments will be recruited by verbal communication. Following informed consent, intraocular pressure (IOP) measurements will be made by the following 3 upright methods and 1 supine measurements:

1. 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.
2. 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. A similar method using an iPod touch camera has been previously published by this PI (1).

3. 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 3 measurements will be randomized.

   The 4th measurement will be made with the patient in the supine position. Here, the subject will be reclined in our standard clinical exam chair until the iris plane is parallel to the ground.

4. Supine applanating prototype: With this method, a 5 gram clear acrylic cylinder (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is aligned with the lens of the CMOS camera and the distal tip of the cylinder is illuminated with blue light using an LED similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. The eye is given topical fluorescein/anesthetic. While the CMOS camera is recording, the 5 gram weight will rest upon the eye and circular applanation mires are recorded. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter. A similar method using an iPhone 6 camera has been previously published by this PI (2). The clear cylinder in this study is the same as that used in this prior study.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Jones, MS; Phone Number: 919-681-6584; Email: sarah.jones1@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Eye Center
      • Contact: Joanne Wen, MD; Email: joanne.wen@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Presenting for a routine eye exam

≥ 18 years of age Able and willing to give consent

Exclusion Criteria:

History of corneal scarring Active infection of the eye

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard GAT; This is the standard method for IOP measurement in clinical practice	Device: Standard GAT; Standard Goldmann Applanation Tonometry (GAT): this is the 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	Device: Fixed force GAT; An investigational device similar to standard GAT
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	Device: Upright applanating prototype; An investigational device, prism used in standard and fixed-force GAT is attached to a portable device
Experimental: Supine Applanating Prototype; With this method, a 5 gram clear acrylic cylinder (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is aligned with the lens of the CMOS camera and the distal tip of the cylinder is illuminated with blue light using an LED similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. The eye is given topical fluorescein/anesthetic. While the CMOS camera is recording, the 5 gram weight will rest upon the eye and circular applanation mires are recorded. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (IOP) as measured by standard 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.	Baseline
Intraocular pressure (IOP) as measured by 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.	Baseline
Intraocular pressure as measured by upright applanating	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.	Baseline
Intraocular pressure as measured by supine applanating protoype	With this method, a 5 gram clear acrylic cylinder (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is aligned with the lens of the CMOS camera and the distal tip of the cylinder is illuminated with blue light using an LED similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. The eye is given topical fluorescein/anesthetic. While the CMOS camera is recording, the 5 gram weight will rest upon the eye and circular applanation mires are recorded. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter.	Baseline

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Joanne Wen, MD, Duke Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: Pro00106111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Currently, there is no plan to share data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No