Eyes With Retinal Diseases, Glaucomatous Eyes, Normal Healthy Subjects With No Known Ocular Diseases
Conditions
Brief summary
Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices
Interventions
Sponsors
Topcon Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Normal Group 1. Subjects 18 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with normal eyes (eyes without pathology) 4. lOPs 21mmHg bilaterally 5. BCVA 20/40 or better (each eye) 6. Both eyes must be free of eye disease
Exclusion criteria
for Normal Group 1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device. 2. Subjects unable to tolerate ophthalmic imaging 3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 4. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5% 5. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses\> 33% or false positives \> 25%, or false negatives \> 25% 6. Presence of any ocular pathology except for cataract 7. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning 8. Narrow angle 9. History of leukemia, dementia or multiple sclerosis 10. Concomitant use of hydroxychloroquine and chloroquine Inclusion Criteria for Glaucoma Group 1. Subjects 18 years of age or older on the date of informed consent 2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subjects presenting at the site with glaucoma 4. BCVA 20/40 or better in the study eye 5. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5% in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optic Disc Measurements (Optic Disc Size) | 1 Hour | Reporting of the Optic Disc Size difference between the Maestro and iVue |
| Retinal Nerve Fiber Layer (RNFL) Thickness Measurements | 1 Hour | RNFL thickness measured |
| Full Retinal Thickness Measurement | 1 Hour | Full Retinal Thicknesses Measurement |
| Optic Disc Measurement (Cup Size) | 1 Hour | Reporting of the Cup size difference between the Maestro and iVue |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Eyes Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes | 58 |
| Glaucomatous Eyes Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes | 24 |
| Eyes With Retinal Diseases Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device
Maestro: OCT machines used for diagnostic purposes
iVue: OCT machines used for diagnostic purposes | 27 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 3 | 7 |
Baseline characteristics
| Characteristic | Normal Eyes | Glaucomatous Eyes | Eyes With Retinal Diseases | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 8 Participants | 8 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 16 Participants | 19 Participants | 90 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 13.3 | 57.8 years STANDARD_DEVIATION 20.2 | 60.5 years STANDARD_DEVIATION 13.4 | 48.7 years STANDARD_DEVIATION 18.1 |
| Optic Disc Area Difference | 0.197 Microns Squared STANDARD_DEVIATION 0.228 | 0.201 Microns Squared STANDARD_DEVIATION 0.262 | 0.097 Microns Squared STANDARD_DEVIATION 0.216 | 0.165 Microns Squared STANDARD_DEVIATION 0.235 |
| Region of Enrollment United States | 58 participants | 24 participants | 27 participants | 109 participants |
| Sex: Female, Male Female | 32 Participants | 10 Participants | 13 Participants | 55 Participants |
| Sex: Female, Male Male | 26 Participants | 14 Participants | 14 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 24 | 0 / 27 |
| serious Total, serious adverse events | 0 / 58 | 0 / 24 | 0 / 27 |
Outcome results
Primary
Full Retinal Thickness Measurement
Full Retinal Thicknesses Measurement
Time frame: 1 Hour
Population: Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Eyes | Full Retinal Thickness Measurement | 22.845 Microns | Standard Deviation 11.482 |
| Eyes With Retinal Diseases | Full Retinal Thickness Measurement | 21.299 Microns | Standard Deviation 24.524 |
Primary
Optic Disc Measurement (Cup Size)
Reporting of the Cup size difference between the Maestro and iVue
Time frame: 1 Hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Eyes | Optic Disc Measurement (Cup Size) | 0 Microns cubed | Standard Deviation 0.072 |
| Glaucomatous Eyes | Optic Disc Measurement (Cup Size) | -0.003 Microns cubed | Standard Deviation 0.124 |
| Eyes With Retinal Diseases | Optic Disc Measurement (Cup Size) | 0.016 Microns cubed | Standard Deviation 0.065 |
Primary
Optic Disc Measurements (Optic Disc Size)
Reporting of the Optic Disc Size difference between the Maestro and iVue
Time frame: 1 Hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Eyes | Optic Disc Measurements (Optic Disc Size) | 0.197 Mircrons squared | Standard Deviation 0.228 |
| Glaucomatous Eyes | Optic Disc Measurements (Optic Disc Size) | 0.097 Mircrons squared | Standard Deviation 0.216 |
| Eyes With Retinal Diseases | Optic Disc Measurements (Optic Disc Size) | 0.201 Mircrons squared | Standard Deviation 0.262 |
Primary
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements
RNFL thickness measured
Time frame: 1 Hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Eyes | Retinal Nerve Fiber Layer (RNFL) Thickness Measurements | 4.682 Microns | Standard Deviation 4.333 |
| Glaucomatous Eyes | Retinal Nerve Fiber Layer (RNFL) Thickness Measurements | 2.526 Microns | Standard Deviation 6.367 |
| Eyes With Retinal Diseases | Retinal Nerve Fiber Layer (RNFL) Thickness Measurements | 4.103 Microns | Standard Deviation 8.789 |