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Tolerability of an Anesthesia-free Tonometer Tip

NCT06585423 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-23

No results posted yet for this study

Summary

The purpose of this study is to compare the tolerability and comfort of 4 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.

Conditions

Interventions

DIAGNOSTIC_TEST

Sterile commercially available bandage contact lens

Medical grade acrylic tip covered by a sterile commercially available bandage contact lens

DIAGNOSTIC_TEST

Medical grade silicone of a thickness <100 µm

Medical grade acrylic tip coated with medical grade silicone of a thickness \<100 µm

DIAGNOSTIC_TEST

Medical grade silicone of a thickness >100 µm

Medical grade acrylic tip coated with medical grade silicone of a thickness \>100 µm

DIAGNOSTIC_TEST

Medical grade silicone of a thickness <100 µm with blur tint

Medical grade acrylic tip coated with medical grade silicone of a thickness \<100 µm with blur tint

DIAGNOSTIC_TEST

Standard tip in conjunction with a topical anesthetic

Standard tip in conjunction with a topical anesthetic

Sponsors & Collaborators

Principal Investigators

  • Joanne Wen, MD · Duke Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-17
Primary Completion
2026-03-02
Completion
2026-03-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06585423 on ClinicalTrials.gov