N/A
N=45
Effect of TrueTear Corneal Surface Imaging
Cataract · Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03637348 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Surface Asymmetry Index (SAI) Assessed With Corneal Topography — 0.21 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TrueTear (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Price Vision Group
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surface Asymmetry Index (SAI) Assessed With Corneal Topography |
0.21 | — |
| SECONDARY Surface Regularity Index (SRI) Assessed With Corneal Topography |
0.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03637348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.