Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)
Conditions
Brief summary
The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.
Interventions
DEVICEApioc Contact Lens
Measurement of corneal oxygen uptake with contact lens wear.
Sponsors
Lentechs, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide informed consent. 2. Appear willing and able to adhere to instructions set forth in the protocol. 3. Be between the ages of 18 and 45. 4. Be an experienced contact lens wearer. 5. Be an eyecare clinician or clinician-in-training. 6. Flat and steep keratometry readings within 40 to 50D. 7. Clear, healthy corneas with no irregular astigmatism. 8. Normal, healthy conjunctiva in both eyes. 9. Be able to provide corneal topography measurements. 10. Be able to provide manifest refraction measurements.
Exclusion criteria
1. Irregular corneal astigmatism. 2. Use of topical or systemic antihistamines within the previous week. 3. Use of topical ophthalmic drops within the previous two days. 4. History of corneal surgery. 5. Currently pregnant or lactating. 6. Systemic disease that would interfere with contact lens wear. 7. Previous diagnosis of dry eye syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Oxygen Uptake Rate | up to 45 seconds | uptake of oxygen by human cornea in vivo |
Countries
United States
Outcome results
None listed