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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,355 Previous Clinical Trials
3,408,819 Total Patients Enrolled
13 Trials studying Glaucoma
2,606 Patients Enrolled for Glaucoma
Joanne Wen, MDPrincipal InvestigatorDuke Eye Center

Media Library

Fixed force GAT (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05235321 — N/A
Glaucoma Research Study Groups: Supine Applanating Prototype, Standard GAT, Fixed-force GAT, Upright applanating prototype
Glaucoma Clinical Trial 2023: Fixed force GAT Highlights & Side Effects. Trial Name: NCT05235321 — N/A
Fixed force GAT (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05235321 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals participate in this research endeavor at the moment?

"Reports on clinicaltrials.gov indicate that this research has been actively recruiting since November 21, 2022 and the trial information was recently updated last month."

Answered by AI

How many participants have enrolled in this investigational research?

"Absolutely. According to clinicaltrials.gov, this particular investigation is actively recruiting participants which began on November 21st 2022 and was last updated on the 30th of that same month. This study requires 200 patients from a single trial site."

Answered by AI
~0 spots leftby Apr 2024