Effect of TrueTear Corneal Surface Imaging
Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2018
CompletedStudy Start
First participant enrolled
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2019
CompletedResults Posted
Study results publicly available
August 3, 2020
CompletedAugust 11, 2020
July 1, 2020
11 months
August 3, 2018
July 3, 2020
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Surface Regularity Index (SRI) Assessed With Corneal Topography
Change from baseline SRI at 5-10 minutes after using the TrueTear device.
Study Arms (1)
TrueTear
OTHERUse of TrueTear device to stimulate tear production
Interventions
Eligibility Criteria
You may qualify if:
- Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Price Vision Grouplead
- Allergancollaborator
Study Sites (1)
Price Vision Group
Indianapolis, Indiana, 46260, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marianne Price, PhD
- Organization
- Cornea Research Foundation of America
Study Officials
- PRINCIPAL INVESTIGATOR
Francis W Price, Jr., MD
Price Vision Group
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2018
First Posted
August 20, 2018
Study Start
August 13, 2018
Primary Completion
July 8, 2019
Study Completion
July 8, 2019
Last Updated
August 11, 2020
Results First Posted
August 3, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share