Effect of TrueTear Corneal Surface Imaging

July 31, 2020 updated by: Price Vision Group

Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: TrueTear
Use of TrueTear device to stimulate tear production
Device: TrueTear
Ues of TrueTear neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline SAI at 5-10 minutes after using the TrueTear device.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline SRI at 5-10 minutes after using the TrueTear device.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Price Vision Group

Collaborators

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 13, 2018

Primary Completion (ACTUAL)

July 8, 2019

Study Completion (ACTUAL)

July 8, 2019

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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