Effect of TrueTear Corneal Surface Imaging

Cataract Clinical Trial

Official title:

Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637348
• Other study ID #: 2018-008
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: July 8, 2019

Study information

• Verified date: July 2020
• Source: Price Vision Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 8, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Myopia

Intervention

Device:
• TrueTear
Ues of TrueTear neurostimulator

Locations

Country	Name	City	State
United States	Price Vision Group	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Price Vision Group	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from baseline SRI at 5-10 minutes after using the TrueTear device.