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OpenTrials
Completed

NCT Number: NCT06585423

Tolerability of an Anesthesia-free Tonometer Tip

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • History of alternated corneal sensitivity
  • History of corneal surgery

Treatment and study plan

Sterile commercially available bandage contact lens

Diagnostic Test

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

Medical grade silicone of a thickness <100 µm

Diagnostic Test

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

Medical grade silicone of a thickness >100 µm

Diagnostic Test

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

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

Diagnostic Test

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

Standard tip in conjunction with a topical anesthetic

Diagnostic Test

Standard tip in conjunction with a topical anesthetic

Primary outcomes

  1. Patient tolerability rating of different tips

    Time frame: Baseline

    Tolerability of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.

  2. Patient comfort rating of different tips

    Time frame: Baseline

    Comfort of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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