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Anesthesia-Free Tonometer Tips for Glaucoma

N/A
Recruiting
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
Active infection of the eye
History of corneal scarring
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the comfort and tolerance of 3 new anesthesia-free tonometer tips with the standard tip used with anesthesia. The goal is to find the most comfortable prototype tip for home use.

Who is the study for?
This trial is for individuals with glaucoma. Participants must be willing to have their eye pressure measured using different tonometer tips without anesthesia to find the most comfortable one.
What is being tested?
The study is testing three prototype tonometer tips made of medical grade silicone (two varying in thickness) and a sterile bandage contact lens against the standard tip with anesthesia, aiming to identify the best option for home use.
What are the potential side effects?
Potential side effects may include discomfort or pain during eye pressure measurement, temporary vision disturbances, or irritation at the site where the tonometer touches the eye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active eye infection.
Select...
I have had scarring on my cornea.
Select...
I have had surgery on my cornea.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient comfort rating of different tips
Patient tolerability rating of different tips

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Medical grade acrylic tip covered by a sterile commercially available bandage contact lensActive Control1 Intervention
Group II: Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µmActive Control1 Intervention
Group III: Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µmActive Control1 Intervention

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Who is running the clinical trial?

Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,810 Total Patients Enrolled
15 Trials studying Glaucoma
2,876 Patients Enrolled for Glaucoma
~33 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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