Effect of TrueTear Corneal Surface Imaging

Price Vision Group

Status: Completed

Conditions: Myopia; Cataract

Treatments: Device: TrueTear

Study type: Interventional

Funder types: Industry

Identifiers

NCT03637348

2018-008

Details and patient eligibility

About

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.

Full description

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

TrueTear

Other group

Description:

Use of TrueTear device to stimulate tear production

Treatment:

Device: TrueTear