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OpenTrials
Completed

NCT Number: NCT03637348

Effect of TrueTear Corneal Surface Imaging

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Price Vision Group

Indianapolis, Indiana, 46260, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TrueTear

Device

Ues of TrueTear neurostimulator

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Price Vision Group

Industry

Collaborators

  • Allergan

Registry information

Official study title

Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2018
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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