Effect of TrueTear Corneal Surface Imaging

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2019-07-08

Brief Summary

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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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Detailed Description

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

Conditions

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Cataract Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TrueTear

Use of TrueTear device to stimulate tear production

Group Type OTHER

TrueTear

Intervention Type DEVICE

Ues of TrueTear neurostimulator

Interventions

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TrueTear

Ues of TrueTear neurostimulator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No