NCT06585423

Tolerability of an Anesthesia-free Tonometer Tip

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Glaucoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-17
• Primary completion: 2026-03-02
• Completion: 2026-03-02
• First posted: 2024-09-05
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study