Effect of TrueTear Corneal Surface Imaging

A study testing TrueTear in people with Cataract and Myopia, run by Price Vision Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cataract, Myopia
What is being tested?: TrueTear
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 13 Aug 2018to 8 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Price Vision Group
Indianapolis, Indiana, 46260

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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

Conditions: Cataract, Myopia
Being tested: TrueTear
Medical subject headings: Cataract, Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TrueTearDevice
Ues of TrueTear neurostimulator

Study groups in NCT03637348
Study group	Role	What they receive
TrueTear	Other	Use of TrueTear device to stimulate tear production Receives: Device: TrueTear

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline SAI at 5-10 minutes after using the TrueTear device.

Secondary outcomes (1)

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.
Measured: Change from baseline SRI at 5-10 minutes after using the TrueTear device.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 20188 Jul 2019

First posted20 Aug 2018
Study start13 Aug 2018
Primary completion8 Jul 2019
Study completion8 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03637348
Sponsor's protocol ID: 2018-008
Status last verified: Jul 2020
First submitted: 3 Aug 2018
Last updated: 11 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
ClinicalTrials.gov ID: NCT03637348
Acronym / sponsor ID: 2018-008
Conditions: Cataract, Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Price Vision GroupIndustry (pharma, biotech, devices)
Collaborators: Allergan
Study start: 13 Aug 2018 (actual)
Primary completion: 8 Jul 2019 (actual)
Study completion: 8 Jul 2019 (actual)
First posted: 20 Aug 2018 (actual)
Results: Posted 3 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TrueTear	Other	Device: TrueTearUse of TrueTear device to stimulate tear production

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TrueTearUes of TrueTear neurostimulator	Device	TrueTear

Primary outcome

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.

1 secondary outcome

Surface Regularity Index (SRI) Assessed With Corneal Topography
Time frame: Change from baseline SRI at 5-10 minutes after using the TrueTear device.

Results and safety

Results posted to the registry on 3 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TrueTear	45	45

Primary outcome: Surface Asymmetry Index (SAI) Assessed With Corneal Topography

Time frame: Change from baseline SAI at 5-10 minutes after using the TrueTear device.. Mean (Standard Deviation). Unit: unitless

Measure	TrueTear n = 45
Value	0.21 (0.34)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the single study visit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TrueTear	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cataract

RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francis W Price, Jr., MD principal investigator

Price Vision Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TrueTear in people with Cataract and Myopia, run by Price Vision Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surface Asymmetry Index (SAI) Assessed With Corneal Topography (time frame: Change from baseline SAI at 5-10 minutes after using the TrueTear device.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03637348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.