Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Price Vision Group
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Surface Asymmetry Index (SAI) Assessed With Corneal Topography
Study Overview
Brief Summary
This study will evaluate the utility of TrueTear™ to improve anterior corneal surface imaging quality before cataract surgery, refractive lens exchange, or laser refractive surgery.
Detailed Description
Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery
Exclusion Criteria
- •A cardiac pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device (e.g. cochlear implant) in the head or neck
- •Chronic or frequent nosebleeds, a bleeding disorder (e.g. hemophilia), or another condition that can lead to increased bleeding
- •A known hypersensitivity (allergy) to the hydrogel material that comes into contact with the inside of the nose during use of the TrueTearTM device
- •Pregnancy
- •Presence of any ocular disease or condition which in the investigator's opinion would confound the study results
Arms & Interventions
TrueTear
Use of TrueTear device to stimulate tear production
Intervention: TrueTear (Device)
Outcomes
Primary Outcomes
Surface Asymmetry Index (SAI) Assessed With Corneal Topography
Time Frame: Change from baseline SAI at 5-10 minutes after using the TrueTear device.
Surface asymmetry index (SAI) is an index that indicates an average value of the corneal power differences between the points spatially located at 180° from 128 equidistant meridians. A radially symmetrical surface has a value of zero, and this value increases as the degree of asymmetry is greater. Higher values are worse, but there is no set maximum value and no unit of measure.
Secondary Outcomes
- Surface Regularity Index (SRI) Assessed With Corneal Topography(Change from baseline SRI at 5-10 minutes after using the TrueTear device.)