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Device

Automated Eye Pressure Measurement for Glaucoma

N/A

Recruiting

Led By Joanne Wen, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age

Be older than 18 years old

Must not have

History of corneal scarring

Active infection of the eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, automated way to measure eye pressure, which may be more accurate and portable than the current standard.

Who is the study for?

This trial is for adults over 18 who are coming in for a routine eye exam and can give consent. It's not suitable for those with a history of corneal scarring or an active eye infection.

What is being tested?

The study is testing new automated methods to measure eye pressure against the standard Goldmann Applanation Tonometry (GAT). This includes two portable prototypes and aims to make the process more objective and repeatable.

What are the potential side effects?

Since this trial involves non-invasive eye pressure measurements, side effects may be minimal but could include discomfort at the site of applanation or temporary visual disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had scarring on my cornea.

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I have an active eye infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intraocular pressure (IOP) as measured by fixed force GAT

Intraocular pressure (IOP) as measured by standard GAT

Intraocular pressure as measured by supine applanating protoype

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Upright applanating prototypeExperimental Treatment1 Intervention

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

Group II: Supine Applanating PrototypeExperimental Treatment1 Intervention

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

Group III: Fixed-force GATExperimental Treatment1 Intervention

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

Group IV: Standard GATActive Control1 Intervention

This is the standard method for IOP measurement in clinical practice

0 / 3Eligibility criteria met