Glaucoma, Retinal Disease
Conditions
Brief summary
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
Interventions
None listed
Sponsors
Topcon Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Retinal Disease Study No Retinal Disease: Inclusion Criteria: * Male or female * Between 18 and 80 years of age * Either eye, but only one eye per subject will be enrolled * Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
Exclusion criteria
* Any known ocular disease * Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc. * Topcon image quality factor ≤ 44 or Stratus signal strength \< 5. Retinal Disease Inclusion Criteria: * Male or female * Between 18 and 80 years of age * Either eye, but only one eye per subject will be enrolled * Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study * A range of retinal thickness will be included * Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | 30 Minutes | The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Subjects Normal Subjects with no known ocular pathology | 20 |
| Retinal Disease Subjects Retinal Disease subjects with ocular pathology | 15 |
| Glaucoma Subjects Glaucoma subjects presented with pathology | 13 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Poor Quality Scans | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Retinal Disease Subjects | Glaucoma Subjects | Normal Subjects | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 4 Participants | 0 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 20 Participants | 34 Participants |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 13.92 | 59.1 years STANDARD_DEVIATION 17.63 | 33.45 years STANDARD_DEVIATION 10.36 | 50.52 years STANDARD_DEVIATION 20.05 |
| Region of Enrollment United States | 15 participants | 13 participants | 20 participants | 48 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 6 Participants | 15 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 / 15 | 0 / 20 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 20 | 0 / 13 |
Outcome results
Primary
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
Time frame: 30 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-IS/OS 3D OCT-1000 | 235.0 µm | Standard Deviation 9.03 |
| Normal Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-IS/OS Stratus | 236.0 µm | Standard Deviation 12.54 |
| Normal Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-RPE 3D OCT-1000 | 252.8 µm | Standard Deviation 7.68 |
| Normal Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-BM 3D OCT-1000 | 296.0 µm | Standard Deviation 8.97 |
| Normal Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | RNFL Thickness 3D OCT-1000 | 107.4 µm | Standard Deviation 10.5 |
| Normal Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | RNFL Thickness Stratus | 105.9 µm | Standard Deviation 9.98 |
| Retinal Disease Eyes | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | RNFL Thickness Stratus | NA µm | — |
| Retinal Disease Eyes | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-IS/OS 3D OCT-1000 | 236.1 µm | Standard Deviation 48.06 |
| Retinal Disease Eyes | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-BM 3D OCT-1000 | 318.5 µm | Standard Deviation 41.9 |
| Retinal Disease Eyes | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | RNFL Thickness 3D OCT-1000 | NA µm | — |
| Retinal Disease Eyes | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-IS/OS Stratus | 263.1 µm | Standard Deviation 48.66 |
| Retinal Disease Eyes | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-RPE 3D OCT-1000 | 279.5 µm | Standard Deviation 45.36 |
| Glaucoma Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-IS/OS Stratus | NA µm | — |
| Glaucoma Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-RPE 3D OCT-1000 | NA µm | — |
| Glaucoma Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | RNFL Thickness Stratus | 72.1 µm | Standard Deviation 20.25 |
| Glaucoma Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-BM 3D OCT-1000 | NA µm | — |
| Glaucoma Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | Retinal Thickness ILM-IS/OS 3D OCT-1000 | NA µm | — |
| Glaucoma Subjects | Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | RNFL Thickness 3D OCT-1000 | 70.7 µm | Standard Deviation 19.87 |