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Effect of TrueTear Corneal Surface Imaging

Primary Purpose

Cataract, Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TrueTear
Sponsored by
Price Vision Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Price Vision Group

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TrueTear

Arm Description

Use of TrueTear device to stimulate tear production

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 3, 2018
Last Updated
July 31, 2020
Sponsor
Price Vision Group
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03637348
Brief Title
Effect of TrueTear Corneal Surface Imaging
Official Title
Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
July 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Price Vision Group
Collaborators
Allergan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Myopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TrueTear
Arm Type
Other
Arm Description
Use of TrueTear device to stimulate tear production
Intervention Type
Device
Intervention Name(s)
TrueTear
Intervention Description
Ues of TrueTear neurostimulator
Primary Outcome Measure Information:
Title
Surface Asymmetry Index (SAI) Assessed With Corneal Topography
Description
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.
Time Frame
Change from baseline SAI at 5-10 minutes after using the TrueTear device.
Secondary Outcome Measure Information:
Title
Surface Regularity Index (SRI) Assessed With Corneal Topography
Description
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.
Time Frame
Change from baseline SRI at 5-10 minutes after using the TrueTear device.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr., MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of TrueTear Corneal Surface Imaging

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