Glaucoma
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTSterile commercially available bandage contact lens
Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
DIAGNOSTIC_TESTMedical grade silicone of a thickness <100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness \<100 µm
DIAGNOSTIC_TESTMedical grade silicone of a thickness >100 µm
Medical grade acrylic tip coated with medical grade silicone of a thickness \>100 µm
DIAGNOSTIC_TESTMedical 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_TESTStandard tip in conjunction with a topical anesthetic
Standard tip in conjunction with a topical anesthetic
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Intraocular pressure measurements using 4 different prototype tips. All standard equipment used to perform Goldmann Applanation Tonometry will be used with the only difference being the applanator tip. The 4 prototypes are as follows and are tested in random order: 1. \- Medical grade acrylic tip covered by a sterile commercially available bandage contact lens (Air Optix, Night and Day Contacts, Alcon). The bandage contact lens will be changed between subjects and the underlying acrylic tip sterilized per standard clinical procedure (bleach soak followed by soak and rinse in sterile water). 2. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \< 100 µm. T 3. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \> 100 µm. 4. \- Medical grade acrylic tip coated with medical grade silicone of a thickness \< 100 µm with blur tint. All tips will be sterilized between subjects 5. \- Standard tip in conjunction with a topical anesthetic
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient tolerability rating of different tips | 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. |
| Patient comfort rating of different tips | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoanne Wen, MD
Duke Eye Center
Outcome results
None listed