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| ID | Type | Description | Link |
|---|---|---|---|
| 399000397 | Other Grant/Funding Number | Gilhuly Accelerator Fund |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical grade acrylic tip covered by a sterile commercially available bandage contact lens | Experimental |
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| Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm | Experimental |
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| Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm | Experimental |
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| Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint | Experimental |
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| Standard tip in conjunction with a topical anesthetic | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile commercially available bandage contact lens | Diagnostic Test | Medical grade acrylic tip covered by a sterile commercially available bandage contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient tolerability rating of different tips | 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. | Baseline |
| Patient comfort rating of different tips | 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Wen, MD | Duke Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
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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:
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| Medical grade silicone of a thickness <100 µm | Diagnostic Test | Medical grade acrylic tip coated with medical grade silicone of a thickness <100 µm |
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| Medical grade silicone of a thickness >100 µm | Diagnostic Test | Medical grade acrylic tip coated with medical grade silicone of a thickness >100 µm |
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| 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 |
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| Standard tip in conjunction with a topical anesthetic | Diagnostic Test | Standard tip in conjunction with a topical anesthetic |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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