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Effect of TrueTear Corneal Surface Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03637348
Recruitment Status : Completed
First Posted : August 20, 2018
Results First Posted : August 3, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Price Vision Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Myopia Device: TrueTear Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : July 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
TrueTear
Use of TrueTear device to stimulate tear production
 Device: TrueTear
Ues of TrueTear neurostimulator


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Surface Regularity Index (SRI) Assessed With Corneal Topography [ Time Frame: Change from baseline SRI at 5-10 minutes after using the TrueTear device. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637348


Locations
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United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Price Vision Group
Allergan
Investigators
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Principal Investigator: Francis W Price, Jr., MD Price Vision Group
  Study Documents (Full-Text)

Documents provided by Price Vision Group:
Study Protocol and Statistical Analysis Plan  [PDF] June 28, 2018

More Information
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Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT03637348    
Other Study ID Numbers: 2018-008
First Posted: August 20, 2018    Key Record Dates
Results First Posted: August 3, 2020
Last Update Posted: August 11, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases