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Automated Applanation Tonometry

Automated Applanation Tonometry

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05235321
Enrollment
118
Registered
2022-02-11
Start date
2022-11-21
Completion date
2024-05-31
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Glaucoma, Suspect

Brief summary

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.

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 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. 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. The clear cylinder in this study is the same as that used in this prior study.

Interventions

Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice

An investigational device similar to standard GAT

An investigational device, prism used in standard and fixed-force GAT is attached to a portable device

DEVICESupine Applanating Prototype

An investigational device, prism used in standard and fixed-force GAT is attached to a portable device performed in the supine position

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

In this study, 3 eye pressure measurements will be made in the upright position (standard GAT, fixed force GAT, upright applanating prototype) and 1 in the supine position (supine applanating prototype).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraocular Pressure (IOP)Single study visit, approximately 20 minutesIntraocular pressure (IOP) as measured by Standard GAT, Fixed-force GAT, and Upright Applanating Prototype.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJoanne Wen, MD

Duke Eye Center

Participant flow

Pre-assignment details

All participants had their intraocular pressure (IOP) measured by all three methods: Standard GAT, Fixed-force GAT, and Upright Applanating Prototype.

Baseline characteristics

Characteristic
Age, Continuous69.0 years
STANDARD_DEVIATION 11.8
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
109 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
5 Participants
Race (NIH/OMB)
Black or African American
28 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
80 Participants
Region of Enrollment
United States
118 Participants
Sex: Female, Male
Female
60 Participants
Sex: Female, Male
Male
58 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1180 / 1180 / 118
other
Total, other adverse events
0 / 1180 / 1180 / 118
serious
Total, serious adverse events
0 / 1180 / 1180 / 118

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026