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This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
This is a pilot evaluation to assess the feasibility of using ultra-high resolution optical coherence tomography (OCT) to image and characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject A (Neophytes) | Active Comparator | Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used. |
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| Subject B (Habitual Lens Wearers) | Active Comparator | Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Contact Lens 1 | Device | Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Bulbar Conjunctival Blood Flow Velocity | Bulbar conjunctival microvascular responses among different types of contact lenses after a period of lens wear will be observed and evaluated for clinical relevance findings. | 4 contact lenses will be tested over a period of 21 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Jiang, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| Marketed Contact Lens 2 | Device | Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). |
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| Marketed Contact Lens 3 | Device | Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). |
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| Marketed Contact Lens 4 | Device | Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes). |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |