Tolerability of an Anesthesia-free Tonometer Tip

Duke University

Status: Enrolling

Conditions: Glaucoma

Treatments: 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; Diagnostic Test: Medical grade silicone of a thickness <100 µm with blur tint; Diagnostic Test: Standard tip in conjunction with a topical anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT06585423

Pro00115919

399000397 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

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

Experimental group

Treatment:

Diagnostic Test: Sterile commercially available bandage contact lens

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

Experimental group

Treatment:

Diagnostic Test: Medical grade silicone of a thickness <100 µm

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

Experimental group

Treatment:

Diagnostic Test: Medical grade silicone of a thickness >100 µm

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

Experimental group

Treatment:

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

Standard tip in conjunction with a topical anesthetic

Active Comparator group

Treatment:

Diagnostic Test: Standard tip in conjunction with a topical anesthetic