Tolerability of an Anesthesia-free Tonometer Tip

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Diagnostic Test: Medical grade silicone of a thickness <100 µm; Diagnostic Test: Medical grade silicone of a thickness >100 µm; Diagnostic Test: Sterile commercially available bandage contact lens

• Registration Number: NCT06585423
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to compare the tolerability and comfort of 3 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-05
• Status Verified: 2024-10
• Study Start: 2024-10-17
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm	Medical grade silicone of a thickness <100 µm	-
Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm	Medical grade silicone of a thickness >100 µm	-
Medical grade acrylic tip covered by a sterile commercially available bandage contact lens	Sterile commercially available bandage contact lens	-

Primary Outcome Measures

Name	Time	Method
Patient tolerability rating of different tips	Baseline	Tolerability of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip
Patient comfort rating of different tips	Baseline	Comfort of 3 different prototype anesthesia-free tonometer tips with the standard tonometer tip

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States