Glaucoma, Glaucoma, Suspect
Conditions
Brief summary
To investigate whether the new applanation tonometer (EyeCheck monitor) can provide intraocular pressure (IOP) measurements comparable to those of traditional tonometers such as the Goldmann applanation tonometer and the Tonopen.
Interventions
DEVICEEyeCheck
EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.
DEVICETraditional Tonometer (Goldmann and Tonopen)
Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All subjects will first take their pressure using the EyeCheck with contact lens in and then remove their lens have pressures taken with Goldmann and Tonopen (two standard of care techniques of taking pressures of the eyes).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 18 years or older, * Any glaucoma patient or glaucoma suspect patient * Presents for an appointment wearing their own soft contact lens.
Exclusion criteria
* Arthritis affecting the upper extremity in the patient or caregiver * Patient unwilling or assessed to be unable to comply with the study protocol * Any corneal abnormalities such as opacities, scars, Fuchs dystrophy, map dot fingerprint dystrophy, history of recurrent corneal abrasion, corneal surgery such as Lasik, PRK, DSAEK, transplant or implant * History of any ongoing ocular symptoms such as eye pain or redness or discharge * History of recent ocular surgery (done in the past 3 months) * History of a any filtering or tube surgery for glaucoma (to reduce risk of infection associated complications) * Recent eye infection (within the past 3 months) * History of diabetes for \> 5 years duration * Monocular patient * Best corrected visual acuity\< 20/70 * Head or hand tremors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) Measurements | Baseline | Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSanjay Asrani, MD
Duke Eye Center
Participant flow
Pre-assignment details
Each study participant was enrolled into both arms. Therefore 22 subjects were enrolled and had testing in each arm.
Participants by arm
| Arm | Count |
|---|---|
| EyeCheck and Traditional Tonometer (Goldmann and Tonopen) EyeCheck pressures will be measured with contact lens in place
EyeCheck: EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.
Pressures will be measured with both Goldmann and Tonopen (both traditional tonometers to take the intraocular pressure (IOP) measurements of the eye).
Traditional Tonometer (Goldmann and Tonopen): Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | EyeCheck and Traditional Tonometer (Goldmann and Tonopen) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 17 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Intraocular Pressure (IOP) Measurements
Compare EyeCheck intraocular pressure (IOP) measurements comparable to those of traditional tonometers (Goldmann and tonopen)
Time frame: Baseline
Population: Participants received both EyeCheck and traditional tonometer measurements.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EyeCheck | Intraocular Pressure (IOP) Measurements | 17.4 mmHg |
| Traditional Tonometer (Goldmann and Tonopen) | Intraocular Pressure (IOP) Measurements | 19.1 mmHg |