Cataract, Myopia
Conditions
Brief 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.
Detailed description
Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.
Interventions
DEVICETrueTear
Ues of TrueTear neurostimulator
Sponsors
Allergan
Price Vision Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface Asymmetry Index (SAI) Assessed With Corneal Topography | 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
| Measure | Time frame | Description |
|---|---|---|
| Surface Regularity Index (SRI) Assessed With Corneal Topography | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TrueTear Use of TrueTear device to stimulate tear production
TrueTear: Ues of TrueTear neurostimulator | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | TrueTear |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 35 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
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.
Time frame: Change from baseline SAI at 5-10 minutes after using the TrueTear device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrueTear | Surface Asymmetry Index (SAI) Assessed With Corneal Topography | 0.21 unitless | Standard Deviation 0.34 |
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.
Time frame: Change from baseline SRI at 5-10 minutes after using the TrueTear device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrueTear | Surface Regularity Index (SRI) Assessed With Corneal Topography | 0.1 unitless | Standard Deviation 0.3 |