Cataract Clinical Trial
Official title:
Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
NCT number | NCT03637348 |
Other study ID # | 2018-008 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 13, 2018 |
Est. completion date | July 8, 2019 |
Verified date | July 2020 |
Source | Price Vision Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 8, 2019 |
Est. primary completion date | July 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Price Vision Group | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Price Vision Group | Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surface Asymmetry Index (SAI) Assessed With Corneal Topography | 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. | Change from baseline SAI at 5-10 minutes after using the TrueTear device. | |
Secondary | Surface Regularity Index (SRI) Assessed With Corneal Topography | Surface Regularity index (SRI) is a local descriptor of surface regularity in a central 4.5 mm diameter area of the cornea. It correlates well with the value of visual acuity (p = 0.80, P <0.001), assuming the cornea is the only limiting factor for vision. A normal cornea presents SRI values below 0.56 (the SRI would be 0 in a perfectly regular cornea). SRI values increase with increasing irregularity of the corneal surface. Higher values are worse, but there is no set maximum value and no unit of measure. | Change from baseline SRI at 5-10 minutes after using the TrueTear device. |
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